Biomedical subjects

R Brase

Publications and source records attributed to R Brase.

9 recordsLinked to original sources

PubMed2001

A multi-centre, double-blind, placebo-controlled study of liposomal prostaglandin E1 (TLC C-53) in patients with acute respiratory distress syndrome.

OBJECTIVE: To evaluate the safety of liposomal PGE1 (TLC C-53) in patients with acute respiratory distress syndrome (ARDS), and determine its efficacy in improving oxygenation and reducing ventilator dependency. DESIGN: A multi-centre, randomized, double-blind, placebo-controlled clinical study. SETTING: Thirty-one hospitals in six European countries. PATIENTS: One hundred two patients with ARDS. INTERVENTIONS: Patients were randomized in a 2:1 ratio to receive infusions of either the study drug TLC C-53 or placebo. Infusions were given over 60 min every 6 h for 7 days. The dose of study drug started at 0.6 microg/kg per h, rising over 24 h to a maximum dose of 1.8 microg/kg per h. MEASUREMENTS AND MAIN RESULTS: Seventy patients received the study drug and 32 placebo. Sixty-nine patients (47 treatment, 22 placebo) completed the study protocol. Patients were monitored for changes in the PaO2/FIO2 ratio, changes in lung compliance, time to off-ventilator and 28-day mortality, in addition to basic haematological and haemodynamic parameters. There were no significant differences in demographics and baseline characteristics between the two groups. There were no differences in the time to off-ventilation (16 days with treatment, 16.6 days with placebo, p=0.94) or in 28-day mortality (30% with treatment, 28% with placebo, p=0.78). There was a difference in the time to achieve a PaO2/FIO2 ratio above 300 in favour of TLC C-53 (10.3 versus 26.5 days) but this was not statistically significant (p=0.23). CONCLUSIONS: TLC C-53 was generally well-tolerated but failed to reduce mortality or duration of mechanical ventilation.

Aged↗

PubMed2001

Randomized, placebo-controlled trial of the anti-tumor necrosis factor antibody fragment afelimomab in hyperinflammatory response during severe sepsis: The RAMSES Study.

OBJECTIVE: This study investigated whether treatment with the anti-tumor necrosis factor-alpha monoclonal antibody afelimomab would improve survival in septic patients with serum interleukin (IL)-6 concentrations of >1000 pg/mL. DESIGN: Multicenter, double-blind, randomized, placebo-controlled study. SETTING: Eighty-four intensive care units in academic medical centers in Europe and Israel. PATIENTS: A total of 944 septic patients were screened and stratified by the results of a rapid qualitative immunostrip test for serum IL-6 concentrations. Patients with a positive test kit result indicating IL-6 concentrations of >1000 pg/mL were randomized to receive either afelimomab (n = 224) or placebo (n = 222). Patients with a negative IL-6 test (n = 498) were not randomized and were followed up for 28 days. INTERVENTIONS: Treatment consisted of 15-min infusions of 1 mg/kg afelimomab or matching placebo every 8 hrs for 3 days. Standard surgical and intensive care therapy was otherwise delivered. MEASUREMENTS AND MAIN RESULTS: The study was terminated prematurely after an interim analysis estimated that the primary efficacy end points would not be met. The 28-day mortality rate in the nonrandomized patients (39.6%, 197 of 498) was significantly lower (p <.001) than that found in the randomized patients (55.8%, 249 of 446). The mortality rates in the IL-6 test kit positive patients randomized to afelimomab and placebo were similar, 54.0% (121 of 224) vs. 57.7% (128 of 222), respectively. Treatment with afelimomab was not associated with any particular adverse events. CONCLUSIONS: The IL-6 immunostrip test identified two distinct sepsis populations with significantly different mortality rates. A small (3.7%) absolute reduction in mortality rate was found in the afelimomab-treated patients. The treatment difference did not reach statistical significance.

APACHE↗

PubMed2000

[Dilated coronary sinus. A preoperative transesophageal echocardiographic diagnosis].

A 36-year old woman was presented to our hospital with congenital ventricular septal defect and one-vessel coronary artery disease (75% proximal left main coronary artery) for CABG and repair of the VSD. After induction, a transesophageal echocardiographic (TEE) baseline examination was performed, showing a severely dilated coronary sinus (CS) measuring approximately 3 cm (abnormal >1 cm). We suggested a persistent left superior vena cava (PLSVC) draining into the CS. PLSVC is a common venous congenital anomaly, with a reported incidence of 0.5% in general population and in 3-5 % of patients with congenital heart defect. Injection of echo-contrast solution in a left arm vein, visualizing microbubbles passing through the PLSVC into the CS confirmed our suspicion. The diagnosis of a PLSVC and dilated CS is a contraindication for retrograde cardioplegia because of the loss of cardioplegia into the PLSVC resulting in a inadequate myocardial protection. It may be difficult to pass a pulmonary artery catheter (PAC) through a left internal or left subclavian vein and it may be associated with arrhythmias. A chest radiograph shows the anomalous course of the PAC along the left heart.

Adult↗

PubMed1998

Outbreaks of Staphylococcus aureus infections during treatment of late onset pneumonia with ciprofloxacin in a prospective, randomized study.

We carried out a prospective, randomized four-center study in nosocomial pneumonia to evaluate the clinical and microbiological efficacy and safety of different treatment regimens in adult intensive care patients. During the randomized treatment of 18 patients with late onset pneumonia, ciprofloxacin (CIP) was compared to ceftazidim plus gentamicin (CAZ/GM), outbreaks of Staphylococcus aureus infections occurred in center 1. This article reports the unexpected findings. In the CIP group six out of ten patients were superinfected or reinfected with ciprofloxacin-resistant pathogens at the follow-up on day 5 after treatment. Four out of these six patients were superinfected with methicillin-susceptible or methicillin-resistant S. aureus (MRSA). Four superinfected patients died with pneumonia during treatment or before the follow-up. In the CAZ/GM group one out of eight patients was superinfected with MRSA. One patient died with pneumonia during treatment. There was no problem with multiresistant S. aureus or MRSA before the study period in center 1. In conclusion, we observed outbreaks of S. aureus infections during the treatment of late onset pneumonia with ciprofloxacin, which were associated with a high mortality. These superinfections occurred in mechanically ventilated, postoperative cardiac surgical patients after 13 days in the intensive care unit (ICU). We recommend combining ciprofloxacin with an antibiotic agent active against gram-positive bacteria in ventilator-associated pneumonia after a prolonged ICU stay. Selective pressure of ciprofloxacin could have played a role in these superinfections.

APACHE↗

PubMed1998

Quantification of mitral regurgitant flow using proximal isovelocity surface area method: a transesophageal echocardiography perioperative study.

OBJECTIVE: To investigate the usefulness of the color Doppler proximal isovelocity surface area (PISA) method, compared with the jet area method, in determining the severity of mitral regurgitation in the perioperative period using angiographic grading as a reference method. DESIGN: Randomized, controlled prospective study. SETTING: Single university hospital. METHODS: Thirty-three patients with native mitral valve insufficiency of different grade were studied. The color jet area in the left atrium, as well as PISA regurgitant stroke volume (RSV), were established. PISA RSV was calculated using a formula derived from previous in vitro and human studies: RSV = 2 pi r2 x v x RTVI/RPFV x (inlet angle/180 degrees), in which r is the radial distance between the first aliasing contour (red/blue interface); v is the aliasing velocity that is read from the color bar; RTVI is the time-velocity integral of the regurgitant jet from the continuous wave Doppler recordings; and RPFV is the corresponding peak flow velocity of the continuous wave regurgitant jet. RESULTS: The rank correlation coefficient between the angiographic grade of mitral regurgitation and the PISA method was rsp = 0.89 (p < 0.0001), and for the jet area was rsp = 0.44 (p < 0.01). There was close concordance between angiographic and PISA measurements of RSV (r = 0.92, p < 0.0001). Further, scatterplot of difference between the two measurements plotted against the mean of measurements showed good agreement. CONCLUSIONS: It was concluded that in patients with mitral regurgitation during the perioperative period, the PISA method is more suitable than the jet area method to determine the severity of mitral regurgitation, and only it provides a reliable technique to differentiate between grade I-II mitral regurgitation in patients with eccentric regurgitant jet and grade III-IV mitral regurgitation in patients with jet size that is bigger than transesophageal echocardiography left atrial size.

Adult↗

PubMed1998

The influence of transoesophageal echocardiography on intra-operative decision making. A European multicentre study. European Perioperative TOE Research Group.

The role of transoesophageal echocardiography (TOE) in anaesthesia remains controversial because it is a rapidly evolving technique with few proven benefits and considerable cost. Recently, the Society of Cardiovascular Anaesthesiologists has published practice guidelines for the use of peri-operative TOE. To determine the current role of transoesophageal echocardiography and the relative impact of category-based transoesophageal echocardiographic indications the present study investigated its use in seven Western European countries. The study sample was taken from a prospective cohort of 224 patients with acute or chronic haemodynamic disturbances or at risk of myocardial ischaemia. All patients were monitored with two-lead electrocardiography and radial and pulmonary artery catheters, as well as biplane or multiplane transoesophageal echocardiography. A total of 2232 clinical interventions were made in these patients. The most frequently observed intervention was the administration of a fluid bolus (45% of all interventions). Overall, transoesophageal echocardiography was the most important guiding factor in 560 (25%) interventions. It was the most important monitor in guiding the following therapeutic interventions: anti-ischaemic therapy--207 of 372 interventions (56%); fluid administration--275 of 996 (28%) interventions; vasopressor or inotrope administration--56 of 316 (16%) interventions; vasodilator therapy--six of 142 (4%) interventions and depth of anaesthesia--four of 211 (2%) interventions. We found that transoesophageal echocardiography is frequently influential in guiding clinical decision making and is used most frequently for category II indications but category I indications were associated with more frequent change in management.

Adult↗

PubMed1997

Confirmatory interleukin-1 receptor antagonist trial in severe sepsis: a phase III, randomized, double-blind, placebo-controlled, multicenter trial. The Interleukin-1 Receptor Antagonist Sepsis Investigator Group.

OBJECTIVE: To determine the therapeutic efficacy and safety of recombinant human interleukin-1 receptor antagonist (rhIL-1ra) in the treatment of patients with severe sepsis. DESIGN: Prospective, randomized, double-blind, placebo-controlled, multicenter trial with a planned, midstudy, interim analysis. SETTING: Ninety-one academic medical center intensive care units in North America and Europe. PATIENTS: Patients with severe sepsis or septic shock (n = 696) received standard supportive care and antimicrobial therapy for sepsis, in addition to rhIL-1ra or placebo. INTERVENTIONS: Patients were randomized to receive either rhIL-1ra (100 mg) or placebo (vehicle) by intravenous bolus, followed by a 72-hr continuous intravenous infusion of either rhIL-1ra (2.0 mg/kg/hr) or placebo. MEASUREMENTS AND MAIN RESULTS: The study was terminated after an interim analysis found that it was unlikely that the primary efficacy end points would be met. The 28-day, all-cause mortality rate was 33.1% (116/350) in the rhIL-1ra treatment group, while the mortality rate in the placebo group was 36.4% (126/346), yielding a 9% reduction in mortality rate (p = .36). The patients were well matched at the time of study entry; 52.9% of placebo-treated patients were in shock while 50.9% of rhIL-1ra-treated patients were in shock at the time of study entry (p = .30). The mortality rate did not significantly differ between treatment groups when analyzed on the basis of site of infection, infecting microorganism, presence of bacteremia, shock, organ dysfunction, or predicted risk of mortality at the time of study entry. No excess number of adverse reactions or microbial superinfections were attributable to rhIL-1ra treatment in this study. CONCLUSIONS: A 72-hr, continuous intravenous infusion of rhIL-1ra failed to demonstrate a statistically significant reduction in mortality when compared with standard therapy in this multicenter clinical trial. If rhIL-1ra treatment has any therapeutic activity in severe sepsis, the incremental benefits are small and will be difficult to demonstrate in a patient population as defined by this clinical trial.

Adult↗

PubMed1994

[Results of immediate and delayed bypass operation in PTCA emergencies].

UNLABELLED: The therapeutic strategy for irreversible coronary occlusion as a complication of PTCA is influenced by the rate of myocardial infarctions and mortality after emergency bypass surgery. If immediate bypass operation cannot prevent myocardial infarction, medication will be the treatment of choice. Since the duration of ischemia is of critical importance for the preservation of myocardium, we analyzed our results with respect to the time interval from the onset of ischemia to surgery. From 12/84 to 12/93 there were 49 emergency operations for 4,478 PTCAs. In 38 patients acute closure occurred in the cath lab; because of very strict standby arrangements these patients could be brought to the operating rooms without delay (group A). In 11 patients acute closure occurred during the following 24 hours in the intermediate care unit (group B); attempts of catheter recanalisation and/or preparation for surgery accounted for an additional time delay until surgery of 79 minutes. RESULTS: In the 38 patients of group A there were only one small transmural (CKmax 533/U/l) and four non-Q wave (CK-max 322 U/l) myocardial infarctions. Of the 11 patients in group B only two did not suffer any loss of myocardium. In seven cases there were transmural (CKmax 1,296 U/l) and in two cases non-Q wave (CKmax 721 U/l) myocardial infarctions. Two patients of group B died on the second and third postoperative day. Thus the results of emergency bypass operations were excellent if surgery could be performed immediately after failure of catheter interventions (all survived, no transmural M.I. in 97%).(ABSTRACT TRUNCATED AT 250 WORDS)

Angioplasty, Balloon, Coronary↗

PubMed1992

[Spontaneous bacterial peritonitis without ascites].

A 34-year-old woman with acute pain in the lower abdomen and a history of non-A-non-B-hepatitis underwent laparotomy. A diffuse light redness of the small bowel without ascites was the only abnormal finding. An appendectomy was performed. The patient deteriorated into a sepsis during the next 60 hours. Relaparotomy established acute diffuse peritonitis with ascites and without any apparent intra-abdominal source of infection. Tracheal, blood, and intraperitoneal cultures of both procedures grew group A streptococci and proved a haematogenous spread of the infection. The sepsis was successfully treated with antibiotics and peritoneal lavage. The course of the infection and the findings are discussed and the case is interpreted as a spontaneous bacterial peritonitis without ascites.

Adult↗