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PubMed2006

Randomized controlled trial of moxifloxacin compared with piperacillin-tazobactam and amoxicillin-clavulanate for the treatment of complicated intra-abdominal infections.

OBJECTIVE: To compare the safety and efficacy of sequential intravenous (IV) to oral (PO) moxifloxacin treatment against a standard antimicrobial regimen of IV piperacillin-tazobactam followed by PO amoxicillin-clavulanate for the treatment of adults with complicated intra-abdominal infection (cIAI). SUMMARY BACKGROUND DATA: cIAIs are commonly due to mixed aerobic and anaerobic bacteria and require both source control and broad-spectrum antibiotic therapy. METHODS: A prospective, double-blind, randomized, phase III comparative trial. Patients with cIAI were stratified by disease severity (APACHE II score) and randomized to either IV/PO moxifloxacin (400 mg q24 hours) or comparator (IV piperacillin-tazobactam [3.0/0.375 g q6 hours] +/- PO amoxicillin-clavulanate [800 mg/114 mg q12 hours]), each for 5 to 14 days. The primary efficacy variable was clinical cure rate at the test-of-cure visit (days 25-50). Bacteriologic outcomes were also determined. RESULTS: : Of 656 intent-to-treat patients, 379 (58%) were valid to assess efficacy (183 moxifloxacin, 196 comparator). Demographic and baseline medical characteristics were similar between the 2 groups. Clinical cure rates at test-of-cure were 80% (146 of 183) for moxifloxacin versus 78% (153 of 196) for comparator (95% confidence interval, -7.4%, 9.3%). The clinical cure rate at test-of-cure for hospital-acquired cIAI was higher with moxifloxacin (82%, 22 of 27) versus comparator (55%, 17 of 31; P = 0.05); rates were similar for community-acquired infections (80% [124 of 156] versus 82% [136 of 165], respectively). Bacterial eradication rates were 78% (117 of 150) with moxifloxacin versus 77% (126 of 163) in the comparator group (95% confidence interval, -9.9%, 8.7%). CONCLUSIONS: Once daily IV/PO moxifloxacin monotherapy was as least as effective as standard IV piperacillin-tazobactam/PO amoxicillin-clavulanate dosed multiple times daily for the treatment of cIAIs.

Abdominal Abscess↗

PubMed1994

Antithrombin III concentrate in the treatment of DIC: a retrospective follow-up study.

OBJECTIVE: To assess the clinical utility of antithrombin III (AT-III) substitution in adults with septicaemia in an intensive care unit. METHODS: A retrospective follow-up study was performed in the adult intensive care unit of a large teaching hospital. Adults with septicaemia and AT-III levels less than 0.45 IU/ml were identified. AT-III administration, consisting of an intravenous bolus injection of 20 IU/kg, followed by continuous infusion of 20 IU/kg per 24 h, was given to 21 patients, while this was withheld in 21 age- and sex-matched controls. The severity of diffuse intravascular coagulation (DIC), APACHE II score, and type of septicaemia were analysed. The odds ratio was calculated for survival. RESULTS: The base-line characteristics with regards to severity of DIC, APACHE scores and types of sepsis were comparable for the patients who received AT-III concentrates and those who did not. Mortality in the treated and non-treated groups was 76% (95% CI: 53-92%) and 57% (95% CI: 34-78%), respectively (p = 0.24). The odds ratio for survival was 2.4 if no AT-III concentrate was administered (95% CI: 0.537-11.5; p = 0.24). CONCLUSIONS: The use of AT-III concentrates in the doses applied in adult intensive care patients with septicaemia does not appear to improve outcome in terms of mortality.

Adult↗

PubMed1998

Preoperative intensive care unit admission and hemodynamic monitoring in patients scheduled for major elective noncardiac surgery: a retrospective review of 95 patients.

OBJECTIVE: To review experience with preoperative intensive care unit (ICU) admission and hemodynamic monitoring to determine which patients benefited and how. DESIGN: Retrospective review over 32-month period (1991 to 1994). SETTING: Surgical ICU of a university teaching hospital. PARTICIPANTS: Ninety-five patients admitted to the surgical ICU before a major elective noncardiac, nonthoracic surgical procedure. INTERVENTIONS: All patients underwent hemodynamic monitoring with a pulmonary artery catheter (PAC). Interventions were made at the discretion of the ICU attending and attending surgeon, based on a general algorithm. Patients were categorized based on history or hemodynamics. The historic classification was as follows: group I, patients with cardiac disease documented by history and cardiac imaging, n = 37; group II, patients with cardiac disease documented by history, but not cardiac imaging, n = 24; group III, patients without documented cardiac disease, but with other significant medical problems, n = 34. Hemodynamic classification considered patients to have subnormal parameters if the cardiac index was < 2.5 L/min/m2, the mixed venous oxygen saturation was < 65%, or the oxygen delivery index was < 350 mL/min/m2 (n = 45), and normal parameters if greater than these (n = 50). MAIN RESULTS: There were no differences in APACHE II scores. Group I patients had greater Goldman Cardiac Risk Indices than group III patients (7.4 +/- 4.8 v 5.0 +/- 3.0). Patients in group I had a significantly greater incidence of subnormal initial hemodynamic values (63%) than patients in group II (47%) or group III (32%). The incidence of postoperative cardiovascular complications among groups was not different. Fifty patients (52%) had normal hemodynamics initially; two (4%) developed postoperative cardiovascular complications compared with 10 patients (22%) of the 45 with subnormal initial hemodynamic values. Of these 45 patients, 24 (52%) had their hemodynamic parameters corrected preoperatively with crystalloids, packed red blood cells, inotropes, and/or afterload reduction. Two of these 24 patients (8%) experienced postoperative cardiovascular complications, compared with 8 of the remaining 21 patients who had no attempt to normalize their hemodynamic values preoperatively other than maintaining a normal pulmonary artery occlusion pressure. CONCLUSIONS: Patients who had normal initial preoperative hemodynamic parameters or abnormal initial parameters that were normalized preoperatively experienced significantly fewer perioperative cardiovascular complications than those with abnormal initial values that were not normalized preoperatively. These results suggest that there may be benefit to the practice of preoperative ICU admission, hemodynamic monitoring with a PAC, and "optimization" of cardiac function in selected patients undergoing major elective noncardiac surgery. Further studies are needed to better delineate the most appropriate patient populations and effective therapeutic protocol.

Adult↗

PubMed2000

Protein C substitution in sepsis-associated purpura fulminans.

OBJECTIVE: To assess the effect of protein C (PC) substitution on imminent peripheral necroses and overall outcome in patients with sepsis-associated purpura fulminans. DESIGN: Case series. SETTING: Intensive care units of two university hospitals. PATIENTS: A total of 12 patients with purpura fulminans, disseminated intravascular coagulation and imminent peripheral necroses in association with sepsis caused by Neisseria meningitidis (n = 5), Streptococcus pneumoniae (n = 2), Capnocytophaga canimorsus (n = 2), and Staphylococcus aureus (n = 1). In two patients, no pathogens were identified. INTERVENTIONS: Intravenous administration of PC concentrate (100 IU/kg every 6 hrs). In addition, antithrombin III substitution, antimicrobial therapy, hemodynamic support, and mechanical ventilation in all patients and hemodiafiltration in 10 patients. MAIN RESULTS: After the onset of PC, progressive peripheral ischemia was reversed irrespective of the etiology of infection. Laboratory variables reflecting disseminated intravascular coagulation improved rapidly, although the recovery of the platelet count was retarded in the patients who subsequently died. No drug-related adverse events were noted. Amputations were necessary in two patients, and necrotic tips of fingers and toes were macerated in a third. The hospital mortality was 42%. Of the five lethal cases, two were caused by S. pneumoniae, one by N. meningitidis, one by C. canimorsus, and one by an unknown pathogen. CONCLUSIONS: This article provides encouraging results on the use of PC substitution in meningococcal purpura and presents new data on the administration of this drug to patients with septic purpura caused by other bacterial species. By clinical judgment, PC limited the extent of tissue necrosis. The small number of patients does not allow for any conclusions on the potential effect of PC on mortality. A controlled and randomized study with a larger number of patients is needed before any recommendations can be given on the use of PC in sepsis-related purpura fulminans and shock.

APACHE↗

PubMed2002

Quality of life effects of antithrombin III in sepsis survivors: results from the KyberSept trial [ISRCTN22931023].

INTRODUCTION: Treatment of sepsis is aimed at increasing both the duration and quality of survival. A long-term focus on quality of life (QoL) in clinical trial evaluations of sepsis care should be a priority. METHOD: QoL data were used to evaluate the effects of intravenous antithrombin III treatment for severe sepsis measured for up to 90 days during the follow-up phase of the KyberSept phase III clinical trial. A visual analog scale and a Karnofsky scale were used to measure physical, psychologic, and social QoL at regular intervals. Changes from baseline between placebo and antithrombin III groups were assessed using Wilcoxon statistical tests, with additional analyses by severity of illness and admitting diagnosis. RESULTS: Among all sepsis survivors in the trial, there was a significant advantage on some attributes of QoL in the antithrombin III subgroup of patients who did not receive heparin as compared with the corresponding placebo group. DISCUSSION: The present study represents the first attempt to evaluate patient QoL over a relatively long period in a large, randomized, placebo-controlled sepsis trial. Over a 90-day period, survivors of severe sepsis receiving antithrombin III experienced significant improvements as compared with placebo on several attributes of QoL. In conclusion, the present study demonstrated that clinical improvements over an extended time period with antithrombin III were complemented by improvements in QoL, particularly in social and psychologic functioning, in many patients.

APACHE↗

PubMed2004

Disorders of hemostasis during the surgical management of severe necrotizing pancreatitis.

OBJECTIVES: Several clinical studies of severe necrotizing pancreatitis (SNP) suggest profound activation of coagulation as well as activation of the fibrinolytic system. The aim of this study was to evaluate the hemostatic derangements in patients who were managed for SNP. METHODS: Forty-one operated-on patients with SNP were analyzed regarding clinical outcome and activation of the coagulation systems. Serial measurement of coagulation, anticoagulation, and fibrinolysis parameters: prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, antithrombin III (AT III), protein C, plasminogen activator inhibitor-1 (PAI-1), d-dimer, alpha2-antiplasmin, and plasminogen were performed on days 1, 3, 5, 7, 10, and 14 after the initial operation. According to treatment outcome at the end of study, groups of 26 survivors and 15 nonsurvivors were compared. RESULTS: Nonsurvivors had significantly lower levels of activity of protein C and AT III, and higher concentrations of d-dimer and PAI-1 than survivors. The other measured parameters did not show significant differences between the compared groups of patients. CONCLUSIONS: Changes in protein C, AT III, d-dimer and PAI-1 levels indicate exhaustion of fibrinolysis and coagulation inhibitors in patients with poor outcome during the course of SNP.

APACHE↗

PubMed2003

Primer Design Assistant (PDA): A web-based primer design tool.

Primer Design Assistant (PDA) is a web interface primer design service combined with thermodynamic theory to evaluate the fitness of primers. It runs in a Linux-Apache-MySQL-PHP structure on a PC equipped with dual CPU (Intel Pentium III 1.4 GHz) and 512 Mb of RAM. A succinct user interface of PDA is accomplished by built-in parameters setting. Advanced options on 5' GC content, 3' GC content, dimer check and hairpin check are available. The option of covered region constrains the PCR product to cover a user-defined segment. PDA accepts single sequence query or multiple ones in FASTA format. It produces optimal and homogenous primer pairs that meet the need in experimental design with large-scaled PCR amplifications. Considering the system loading, the size of a submitted sequence is limited to 10 kb and the total sequence number in a query is limited to 20. The authors may be contacted regarding other requirements for primer design. The web application can be found at http://dbb.nhri.org.tw/primer/.

DNA Primers↗

PubMed1998

Patterns of neurophysiological abnormality in prolonged critical illness.

OBJECTIVE: To describe the various patterns of neurophysiological abnormalities which may complicate prolonged critical illness and identify possible aetiological factors. DESIGN: Prospective case series of neurophysiological studies, severity of illness scores, organ failures, drug therapy and hospital outcome. Some patients also had muscle biopsies. SETTING: General intensive care unit (ICU) in a University Hospital. PATIENTS: Forty-four patients requiring intensive care unit stay of more than 7 days. The median age was 60 (range 27-84 years), APACHE II score 19 (range 8-33), organ failures 3 (range 1-6), and mortality was 23%. RESULTS: Seven patients had normal neurophysiology (group I), 4 had a predominantly sensory axonal neuropathy (group II), 11 had motor syndromes characterised by markedly reduced compound muscle action potentials and sensory action potentials in the normal range (group III) and 19 had combinations of motor and sensory abnormalities (group IV). Three patients had abnormal studies but could not be classified into the above groups (group V). All patients had normal nerve conduction velocities. Electromyography revealed evidence of denervation in five patients in group III and five in group IV. There was no obvious relationship between the pattern of neurophysiological abnormality and the APACHE II score, organ failure score, the presence of sepsis or the administration of muscle relaxants and steroids. A wide range of histological abnormalities was seen in the 24 patients who had a muscle biopsy; there was no clear relationship between these changes and the neurophysiological abnormalities, although histologically normal muscle was only found in patients with normal neurophysiology. Only three of the eight patients from group III in whom muscle biopsy was performed had histological changes compatible with myopathy. CONCLUSIONS: Neurophysiological abnormalities complicating critical illness can be broadly divided into three types -- sensory abnormalities alone, a pure motor syndrome and a mixed motor and sensory disturbance. The motor syndrome could be explained by an abnormality in the most distal portion of the motor axon, at the neuromuscular junction or the motor end plate and, in some cases, by inexcitable muscle membranes or extreme loss of muscle bulk. The mixed motor and sensory disturbance which is characteristic of 'critical illness polyneuropathy' could be explained by a combination of the pure motor syndrome and the mild sensory neuropathy. More precise identification of the various neurophysiological abnormalities and aetiological factors may lead to further insights into the causes of neuromuscular weakness in the critically ill and ultimately to measures for their prevention and treatment.

Adult↗

PubMedDate not supplied

[Disturbances of protein C activity in abdominal sepsis: diagnostic and predictive importance].

BACKGROUND: Despite improved diagnostic modalities, potent antibiotics, modern intensive care, and aggressive surgical treatment, more than one third of patients still die of severe secondary peritonitis. Clinical difficulties in the treatment of abdominal sepsis were related to inherent problems of limited clinical signs and the rapid spread of infection. An inflammatory process is often well under way before the presence of clinical signs and symptoms of sepsis. The aim of this prospective study was to assess diagnostic and prognostic significance of protein C in abdominal sepsis. METHODS: Twenty-two patients with severe intraabdominal infections with sepsis syndrome were treated surgically as compared to 15 patients with hernia repair (control group). During the study, the following parameters were analyzed daily: protein C, AT III, plasminogen, alfa-2 antiplasmin, HMWK, C5a and C5-B9 complement, C1-inhibitor, CRP. RESULTS. The mean APACHE II score was 17 points, with actual mortality rate of 23%. Each parameter evaluated in the abdominal sepsis group differed from the one evaluated in the control group to a great extent (p = 0.001). The results and multivariate regression statystical analysis confirmed the following parameters as sensitive biological markers of septic cascade (p < 0.0001-0.026): protein C, AT III, HMWK, C1-inhibitor and C5-B9 complement. According to the results the low level of protein C consistently correlated with disease severity and suggested the development of septic shock and poor outcome. CONCLUSION: Early diagnosis of plasma proteolytic disturbances was very important, from the diagnostic and predictive point of view, in abdominal sepsis. According to the results protein C was the most significant marker of sepsis and early predictor of the outcome of septic complications during severe intraabdominal infections (r = 0.761; p = 0.0001).

Abdomen↗

PubMedDate not supplied

[Dynamic pancreatography: the diagnosis of pancreatic necrosis and the identification of the risk factors of severity].

BACKGROUND: Dynamic pancreatography (DP) can establish the development of tissue damage and demonstrate pancreatic necrosis (PN). OBJECTIVE: To prospectively evaluate the usefulness of DP in patients with acute pancreatitis (AP), analyzing its capabilities for determining the incidence of necrosis, and as a prognostic predictor. MATERIAL AND METHODS: All patients with AP seen at our department during 4 years were included. All patients were scheduled to DP. Findings were classified in five groups: I, interstitial AP; II, secondary fluid collections; III, peripancreatic necrosis; IV, pancreatic necrosis < 50% and pancreatic necrosis > 50%. Also included for analysis were: demographic variables, etiology, APACHE-II score, and Ranson's signs; when infection was suspected, cultures were done. PD and operative findings were correlated to calculate sensibility (S), specificity (Sp), positive and negative predictive values (PPV, NPV), and the diagnostic accuracy (DA) of the test. Correlation between severity/mortality and morphologic alterations according to the classified group were also performed. RESULTS: 244 patients. Biliary associated pancreatitis in 47% and alcohol induced in 37%. DP in 207 patients showed, 34 patients in group I; 36 in group II, 67 in group III, 47 and 60 in groups IV and V, respectively. Secondary pancreatic infection was present in 48%. One hundred seventy-two patients underwent surgery; the surgical indication was to interrupt the pathogenesis of complications in 52%. DP correlated with the prognostic signs and APACHE-II score as predictors of complications with an overall (S) of 93%, (Sp) 98%, (PPV) 91%, (NPV) 98%, and (DA) 97%. Greater scores values are all directly proportional with PD necrosis findings (P < 0.05). There was not PD related morbidity. CONCLUSIONS: We found correlation between PD classification and prognostic factors. Morphologic alterations were accurately identified. PD as preoperative work-up allows surgeons design operative strategies and as is useful follow-up of the patients after necrosectomy.

APACHE↗

PubMed2003

Lipoprotein metabolism in patients with severe sepsis.

OBJECTIVE: Lipoproteins have been implicated to play a role in innate immunity. Changes in lipoprotein levels have been reported in a variety of inflammatory disorders. Not much is known about lipoprotein metabolism in patients with severe sepsis. We conducted an ancillary study in a multiple-center phase III sepsis trial to investigate the dynamics of plasma lipoproteins in patients with severe sepsis. DESIGN: Prospective analysis in patients meeting criteria for severe sepsis as part of a multiple-center sepsis study (KyberSept) with antithrombin III (Kybernin P). SETTING: University hospital intensive care unit. PATIENTS: Seventeen patients were included in the study. INTERVENTIONS: Randomized patients received a loading dose of 6000 IU of antithrombin III (Kybernin P) or placebo followed by a 96-hr continuous infusion of 250 IU/hr antithrombin III (Kybernin P) or placebo. In each patient, serial blood samples for total cholesterol, lipoprotein cholesterol, triglycerides, apolipoprotein A-1, apolipoprotein B, and C-reactive protein determination as well as clinical data were collected over 28 days. MEASUREMENTS AND MAIN RESULTS: Plasma cholesterol levels rapidly decreased from 2.67 +/- 2.02 mmol/L on day 0 to a nadir of 1.41 +/- 0.70 mmol/L on day 3, followed by a slow increase to 4.18 +/- 1.94 mmol/L on day 28. High-density lipoprotein (HDL) cholesterol concentrations decreased rapidly from 0.84 +/- 0.92 mmol/L to a nadir of 0.42 +/- 0.35 mmol/L on day 3, to show a slow increase during the following 4 wks to 0.84 +/- 0.42 mmol/L. The low-density lipoprotein (LDL) cholesterol concentrations were already low (0.94 +/- 0.81 mmol/L) at study entry, to show a progressive increase to subnormal values (2.01 +/- 0.94 mmol/L) at 4 wks. Nadir and recovery lipoprotein concentrations were significantly different (paired Student's t-test, p <.05). A significant correlation was found between HDL cholesterol and apolipoprotein A-1 (r =.714, p <.05) and between LDL cholesterol and apolipoprotein B (r =.733, p <.05). There was no statistical difference in lipoprotein concentrations either between survivors and nonsurvivors or between patients receiving antithrombin III or placebo. Serum amyloid A was a major apoprotein (45%) in HDL at the start of the sepsis and was slowly replaced by apolipoprotein A-1 during recovery. A positive correlation was found between plasma C-reactive protein concentrations and serum amyloid A concentrations in HDL (r =.684, p <.05). No other relevant correlations were found between inflammatory and lipoprotein parameters. CONCLUSIONS: In patients with severe sepsis, lipoprotein concentrations rapidly change and can be reduced to 50% of recovery concentrations. The pattern of early rapid decline is found primarily in the HDL and a slow recovery in both HDL and LDL fractions. The correlation between apolipoprotein and lipoprotein cholesterol concentrations suggests a decline in lipoprotein particles. During severe sepsis, HDL is shifted to acute phase HDL, which is enriched in serum amyloid A and depleted of cholesterol and apolipoprotein A-1. Lipoprotein concentrations are unable to discriminate between survivors and nonsurvivors.

APACHE↗

PubMed1996

Prognostic indexes and mortality in critically ill patients with acute renal failure treated with different dialytic techniques.

The objective of this study was to compare the evolution of patients with acute renal failure (ARF) treated conservatively or with different dialytic techniques in an intensive care unit (ICU). From June 1992 to November 1994, 1087 consecutive patients were admitted in our ICU. Two hundred and twenty of these presented with ARF, and were divided into three groups; group I (control group): 156 patients with ARF who did not receive substitutive techniques; group II: 21 patients under intermittent hemodialysis (IHD) or peritoneal dialysis (PD); group III: 43 patients under continuous hemodiafiltration (CHDF). The studied variables were age, etiology of renal failure, requirement of dialysis, type of dialysis, length of ICU and hospital stay, and renal function outcome. APACHE II and SAPS scores were recorded on admission and analyzed for hospital mortality. Chi-square test and the analysis of variance were used for the statistical analysis. Results are presented as mean +/- SD. A p value below 0.05 was considered statistically significant. Although etiology of ARF was multifactorial, we found a high frequency of ARF due to sepsis (56.8%), hypoperfusion (58.7%), and acute tubular necrosis (62.5%). Sepsis and heart failure were clinical conditions associated to a greater mortality. We did not find any statistical difference between the two dialyzed groups for all the studied variables, nor between the three groups regarding APACHE II and hospital stay. Significant differences were found between dialyzed and non-dialyzed patients respect to age, group I: 64.1 +/- 13.6, group II: 56.4 +/- 19.7, and group III: 56.0 +/- 14.1 (p < 0.001), creatinine peak serum levels, group I: 260 +/- 130, group II: 494 +/- 209, and group III: 441 +/- 170 mumol/L (p < 0.0001), and mortality, group I: 46.9%, group II: 66.7%, and group III: 76.2% (p < 0.002). SAPS score showed differences between the control group and the CHDF group 13.9 +/- 4.8 and 16.4 +/- 5.4 (p < 0.007), respectively. The use of dialytic techniques in critically ill ARF patients is associated with greater mortality. Prognostic indexes on admission did not correctly classify our patients with ARF. Continuous hemodiafiltration does not involve greater mortality or length of stay as compared to conventional dialysis.

Acute Kidney Injury↗

PubMed1998

Significant correlations between tissue factor and thrombin markers in trauma and septic patients with disseminated intravascular coagulation.

To determine the role of plasma tissue factor on disseminated intravascular coagulation (DIC) in trauma and septic patients, and also to investigate the relationships between tissue factor and various thrombin markers, we made a prospective cohort study. Forty trauma patients and 20 patients with sepsis were classified into subgroups according to the complication of DIC. Plasma tissue factor antigen concentration (tissue factor), prothrombin fragment F1+2 (PF1+2), thrombin antithrombin complex (TAT), fibrinopeptide A (FPA), and D-dimer were measured on the day of admission (day 0), and on days 1, 2, 3, and 4 after admission. The levels of plasma tissue factor in the DIC group were more elevated than those of the non-DIC group in both the trauma and the septic patients. In patients with sepsis, tissue factor levels on days 0 through 4 in the non-DIC group showed markedly higher values than those in the control patients (135 +/- 8 pg/ml). Significant correlations between tissue factor and PF1+2, TAT, FPA, and D-dimer were observed in the DIC patients, however, no such correlations were found in the non-DIC patients. These results suggest that elevated plasma tissue factor in patients with trauma and sepsis gives rise to thrombin generation, followed by intravascular coagulation.

APACHE↗

PubMed2003

Effect of filtration volume of continuous venovenous hemofiltration in the treatment of patients with acute renal failure in intensive care units.

OBJECTIVE: We evaluated the variable Kt/V, which has become established in the therapy of end-stage renal disease in acute renal failure, to assess the influence of the filtration volume of continuous venovenous hemofiltration on Kt/V. We measured the variables of acid-base balance and uremia control. DESIGN: Prospective interventional pilot study. SETTING: Medical intensive care unit of a university hospital. PATIENTS: Fifty-six patients with acute renal failure and continuous venovenous hemofiltration treatment. INTERVENTIONS: The patients were consecutively treated with a filtration volume of either 1 L/hr (group 1) or 1.5 L/hr (group 2). MEASUREMENTS AND MAIN RESULTS: Patients with a filtration volume of 1.5 L/hr achieved a Kt/V of 0.8 per day, which was significantly higher than in the patient group treated with 1 L/hr (0.53, p <.05). The filtration volume of 1.5 L/hr led to a markedly better control of blood urea nitrogen concentrations, 69.3 +/- 6.6 mg/dL vs. 52.1 +/- 5.2 (p <.05), and to a much quicker and longer lasting compensation of acidosis. Both groups had acidotic pH at the beginning of therapy (group 1, 7.29 +/- 0.02; group 2, 7.29 +/- 0.02, nonsignificant). In group 2, a significantly higher pH value than in group 1 was measured after 24 hrs of continuous venovenous hemofiltration (p < .001; 7.39 +/- 0.02 vs. 7.31 +/- 0.02). The pH values in group 1 did not normalize until after 4 days. The filtration volume of 1.5 L/hr led to a quicker increase in bicarbonate concentrations after 24 hrs of therapy (group 1, 2.8 +/- 3.2 mmol/L; group 2, 6.5 +/- 3.1 mmol/L, p <.001). CONCLUSIONS: The standardized urea clearance Kt/V is a valuable tool in the treatment of acute renal failure. Higher Kt/V levels were associated with a better control of uremia and acid-base balance. However, there were no differences in the clinical course, patient survival, percentage of patients with or without renal failure who were transferred from the intensive care unit, or Acute Physiology and Chronic Health Evaluation III scores.

APACHE↗

PubMedDate not supplied

Prognostic factors and scoring system for survival in colonic perforation.

BACKGROUND/AIMS: No ideal and generally accepted prognostic factors and scoring systems exist to determine the prognosis of peritonitis associated with colonic perforation. This study was designed to investigate prognostic factors and evaluate the various scoring systems to allow identification of high-risk patients. METHODOLOGY: Between 1996 and 2003, excluding iatrogenic and trauma cases, 26 consecutive patients underwent emergency operations for colorectal perforation and were selected for this retrospective study. Several clinical factors were analyzed as possible predictive factors, and APACHE II, SOFA, MPI, and MOF scores were calculated. RESULTS: The overall mortality was 26.9%. Compared with the survivors, non-survivors were found more frequently in Hinchey's stage III-IV, a low preoperative marker of pH, base excess (BE), and a low postoperative marker of white blood cell count, PaO2/FiO2 ratio, and renal output (24h). According to the logistic regression model, BE was a significant independent variable. Concerning the prognostic scoring systems, an APACHE II score of 19, a SOFA score of 8, an MPI score of 30, and an MOF score of 7 or more were significantly related to poor prognosis. CONCLUSIONS: Preoperative BE and postoperative white blood cell count were reliable prognostic factors and early classification using prognostic scoring systems at specific points in the disease process are useful to improve our understanding of the problems involved.

APACHE↗

PubMed1998

Twenty-four-hour urinary free cortisol in patients with acquired immunodeficiency syndrome.

Many patients with acquired immune deficiency syndrome (AIDS) have symptoms consistent with adrenal insufficiency, but only a small subset of these patients meet criteria for adrenal insufficiency during a short corticotropin (ACTH) stimulation test. We hypothesized that patients with AIDS and symptoms of adrenal insufficiency who produce normal amounts of cortisol in response to administration of 0.25 mg cosyntropin may nevertheless produce lower amounts of cortisol in a course of 24 hours than comparably sick AIDS patients without symptoms of adrenal insufficiency or comparably sick patients without AIDS. We studied four groups of male patients: AIDS patients with symptoms suggestive of adrenal insufficiency but with a normal response to cosyntropin (group I), AIDS patients without symptoms suggestive of adrenal insufficiency (group II), human immunodeficiency virus (HIV)-negative patients with serious acute or chronic illness (group III), and healthy subjects (group IV). The following variables were examined: age, CD4 cell count, Acute Physiologic and Chronic Health Evaluation (APACHE) score, serum cortisol and plasma ACTH at baseline; serum cortisol at 30 and 60 minutes after intravenous administration of 0.25 mg cosyntropin; and 24-hour urinary free cortisol. The four groups had a similar mean age and baseline plasma ACTH and serum cortisol levels. However, a change in cortisol from baseline to 30 and 60 minutes after administration of cosyntropin was significantly smaller in both groups of AIDS patients than in the sick patients without AIDS and normal subjects. There were also differences noted between the two groups of AIDS patients: both baseline and stimulated levels of cortisol tended to correlate directly with ACTH levels in patients without symptoms of adrenal insufficiency, while this relationship appeared to be inverse in patients with symptoms suggestive of adrenal insufficiency (r = -.57 to -.7, P < .05 to .14). The 24-hour urinary free cortisol levels were similar among all groups, but correlated strongly with baseline and stimulated serum cortisol levels only in patients with AIDS and symptoms of adrenal insufficiency (r = .8 to .9, P < .002 to .015). We conclude that (1) AIDS patients with and without symptoms of adrenal insufficiency may have either normal adrenal function or somewhat suboptimal adrenal reserve as demonstrated by a blunted cortisol response during the short ACTH stimulation test in comparison to HIV-negative comparably sick patients or healthy subjects; and (2) 24-hour urinary free cortisol is not a useful test for detection of subtle abnormalities of adrenal function in patients with AIDS.

Acquired Immunodeficiency Syndrome↗

PubMed2005

Lack of evidence for qualitative treatment by disease severity interactions in clinical studies of severe sepsis.

INTRODUCTION: The design of clinical trials of interventions aimed at reducing mortality in patients with severe sepsis assumes that the relative treatment effect of the intervention is independent of the patients' risk for death. We reviewed published data from phase III clinical studies of severe sepsis to determine whether a relationship exists between risk for death and the relative benefit of the investigational agent. Such an interaction might warrant a change in the assumptions that underlie current trial designs. METHODS: We conducted a systematic review of published phase III, randomized, placebo-controlled trials in adult patients with sepsis, severe sepsis, or septic shock up to November 2004. All studies enrolled patients with known or suspected infection, evidence of a systemic response to the infection, and one or more organ dysfunctions resulting from the systemic response. RESULTS: Twenty-two publications, investigating 17 molecular entities, fulfilled criteria for phase III or equivalent studies aimed at reducing mortality in adult patients with severe sepsis or septic shock. Three studies achieved the prospectively defined primary end-point of a statistically significant reduction in 28-day all-cause mortality. The control group mortality rates for these studies were 31%, 43% and 61%, indicating that the beneficial effects of adjunct therapies could be demonstrated over a wide range of illness severity. Analysis of subgroup data from failed studies provided no evidence that the efficacy of the therapeutics being investigated varied by baseline placebo mortality rates. Among all studies, interventions with anticoagulant activity or anti-inflammatory activity did not appear to be harmful in patients with evidence of less coagulopathy or less inflammation. CONCLUSION: Our review of published clinical data does not support the hypothesis that mortality risk of the population studied alters the relative treatment effect associated with anti-inflammatory or other agents used to treat severe sepsis. Clinical studies in severe sepsis should continue to enroll patients over a wide range of disease severity, as long as patients enrolled have evidence of sepsis-induced organ dysfunction(s), patients are at an appreciable risk for death (e.g. as evidenced by admission to an intensive care unit), and the potential for benefit outweighs the potential for harm.

APACHE↗

PubMed2005

The staging of sepsis: understanding heterogeneity in treatment efficacy.

Human sepsis is an intrinsically complex disease. Populations of patients enrolled into clinical trials of novel sepsis therapies are notoriously heterogeneous with respect to the inciting cause of their disease, the co-morbid conditions that define its course, and the acute severity of their initial presentation. This heterogeneity is reflected in strikingly variable mortality risks across studies, and probably, though less clearly-established, in variable response rates to a given intervention. In an accompanying article in this issue of Critical Care, Macias and colleagues argue that the effectiveness of adjuvant sepsis therapies is not dependent on the baseline mortality risk, since the few "positive" trials that have been published show widely divergent placebo mortality rates. But this analysis assumes that biologically distinct interventions will be equally efficacious in clinically diverse populations, and confuses severity as a population descriptor with severity as a surrogate measure of a biologic state in an individual patient. In a pivotal trial of recombinant human activated protein C (rhAPC) in patients with severe sepsis, an aggregate 6% mortality decrement appeared to be the result of negligible efficacy in the least severely ill patients, and considerably greater efficacy in those who were at greatest risk of dying. A larger follow-up study recruiting low risk patients confirmed this impression, showing a convincing absence of benefit in patients who clinicians judged to be less severely ill. If we accept Macias' argument, we are led to the conclusion that rhAPC is of limited use in the management of severe sepsis. On the other hand, if we view severity as a crude surrogate for a particular pathologic state, we would shift our focus to better defining those populations most likely to benefit from intervention, including patients who may not have met criteria for entry in the original PROWESS trial--those with disseminated intravascular coagulation or acute organ dysfunction from causes other than sepsis. Staging systems that stratify heterogeneous patient populations by risk and by potential to benefit from intervention have proven to be essential to the development of multimodal adjuvant treatment for cancer. They will be no less important in the optimal management of sepsis.

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