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PubMed2000

A prospective multicenter comparison of peritonitis in peritoneal dialysis patients aged above and below 65 years. Levante PD Multicenter Group.

Various authors have found peritonitis rates in older peritoneal dialysis (PD) patients to be higher, similar, or even lower when compared to rates in younger populations. We prospectively analyzed all episodes of peritonitis registered in the 381 patients (219 males, 162 females; mean age, 55.5 +/- 17.0 years) who were treated with PD during four years (1993-1996) in our multicenter group. Patients were distributed into two groups. Group A included 138 patients aged 65 years or over (mean age: 72.3 +/- 5.1 years); group B included 243 patients aged below 65 years (mean age: 46.0 +/- 13.6 years). No differences were seen in general PD characteristics. Normalized protein catabolic rate (nPCR) was higher in younger patients (p = 0.001). Patients in group A experienced more peritonitis (135 episodes; 1 episode per 16.7 patient-months) than patients in group B (198 episodes; 1 episode per 21.7 patient-months; p = 0.01). Although no differences were seen in the general characteristics of the peritonitis episodes, gram-negative peritonitis and peritonitis not achieving a cure were more commonly secondary to enteric bacteria in group A (p = 0.03). We conclude that PD patients aged 65 years or over are at higher risk of peritonitis. Also, in this age group, gram-negative peritonitis and peritonitis with any evolution except cure are more likely to be due to enteric bacteria.

Age Factors↗
PubMedDate not supplied

Reversal of central nervous system effects by flumazenil after intravenous conscious sedation with midazolam: report of a multicenter clinical study. The Flumazenil in Intravenous Conscious Sedation with Midazolam Multicenter Study Group I.

Flumazenil, a benzodiazepine antagonist, reverses the residual central nervous system effects of benzodiazepines. In this US double-blind, multicenter study, the efficacy of flumazenil was compared with that of placebo in antagonizing the effects of midazolam, a benzodiazepine used to induce intravenous conscious sedation. The mean dose of flumazenil was 0.7 mg, administered intravenously. At 5 minutes posttreatment, 82% of 131 flumazenil-treated patients, compared with 15% of 65 placebo-treated patients, demonstrated complete reversal of sedation. In 85% of patients who responded to flumazenil, this reversal of sedation was maintained throughout the 180-minute observation period. Psychomotor performance returned to prestudy levels 5 minutes posttreatment in 87% of the flumazenil-treated patients, compared with 28% of the placebo-treated patients. At the doses administered, flumazenil was less effective in reversing midazolam-induced amnesia, with only 60% of patients demonstrating partial recovery of memory. It was, nevertheless, more effective than placebo. Flumazenil was well tolerated. Dizziness (10%) and nausea (9%) were the most frequently reported adverse effects. Results of this study demonstrate that flumazenil antagonizes the central nervous system effects of midazolam after intravenous conscious sedation.

Adolescent↗
PubMedDate not supplied

Reversal of central benzodiazepine effects by intravenous flumazenil after conscious sedation with midazolam and opioids: a multicenter clinical study. The Flumazenil in Intravenous Conscious Sedation with Midazolam Multicenter Study Group II.

The efficacy and safety of flumazenil in antagonizing the central effects of the benzodiazepine midazolam was demonstrated in patients in whom conscious sedation was induced with midazolam plus an opioid (fentanyl, meperidine, or morphine). In a double-blind, multicenter study, 240 patients were administered flumazenil postoperatively at an average intravenous dose of 0.7 mg (7 ml) and 114 patients were administered an average dose of 9 ml placebo. Complete reversal of sedation was observed in 80% of flumazenil-treated patients and 30% of placebo-treated patients 5 minutes posttreatment. In 87% of patients who responded to flumazenil, the level of alertness was maintained throughout the 180-minute observation period. Midazolam-impaired psychomotor performance returned to normal 5 minutes posttreatment in 80% of the flumazenil-treated patients and 28% of the placebo-treated patients. Flumazenil was less effective in reversing midazolam-induced amnesia, with only 70% of flumazenil-treated patients (and 15% of placebo-treated patients) able to recall the picture shown them at the 5-minute assessment, and fewer patients able to recall pictures shown at later times. Flumazenil was well tolerated, although adverse effects were reported slightly more often than in the placebo group. The most frequent adverse events in both groups were dizziness and nausea. Vital signs were not affected.

Adolescent↗
PubMedDate not supplied

Reversal of central benzodiazepine effects by flumazenil after intravenous conscious sedation with diazepam and opioids: report of a double-blind multicenter study. The Flumazenil in Intravenous Conscious Sedation with Diazepam Multicenter Study Group II.

The efficacy and safety of a new benzodiazepine antagonist, flumazenil, were assessed in a double-blind multicenter study. Flumazenil (mean dose, 0.76 mg) or placebo (mean dose, 8.9 ml) was administered intravenously to 130 and 67 patients, respectively, who had been given diazepam in conjunction with an opioid (fentanyl, meperidine, or morphine) for the induction and maintenance of intravenous conscious sedation for diagnostic or therapeutic surgical procedures. The group assessable for efficacy comprised 122 patients treated with flumazenil and 64 patients given placebo. After 5 minutes, 80/115 (70%) flumazenil-treated patients, compared with 21/63 (33%) placebo-treated patients, were completely awake and alert, as indicated by a score of 5 on the Observer's Assessment of Alertness/Sedation Scale. Ninety-five percent of patients in each group who attained a score of 5 at the 5-minute assessment showed no loss of alertness throughout the 180-minute assessment period. Flumazenil-treated patients also performed significantly better on the Finger-to-Nose Test and the recall of pictures shown at the 5-minute assessment. Flumazenil was well tolerated, with no serious adverse effects reported. Thirty-nine (30%) of flumazenil-treated patients, compared with 17 (25%) of placebo-treated patients had one or more drug-related adverse experiences. The most common adverse effects were nausea and vomiting in the flumazenil group and nausea and injection-site pain in the placebo group. Flumazenil was found to promptly reverse sedation induced by diazepam in the presence of opioids.

Adolescent↗
PubMed1992

Relapse-preventing effect and safety of sulfasalazine and olsalazine in patients with ulcerative colitis in remission: a prospective, double-blind, randomized multicenter study. The Ulcerative Colitis Multicenter Study Group.

Forty-nine patients with ulcerative colitis in remission were entered into a prospective, double-blind, multicenter trial comparing the relapse-preventing effect and safety of 4 g sulfasalazine and 2 g olsalazine daily during 48 wk. Of the 46 evaluable patients, 23 were assigned to sulfasalazine and 23 to olsalazine. Seven of 23 patients (30.4%) relapsed on sulfasalazine and six of 23 patients (26.1%) on olsalazine (95% confidence interval of the difference -22.0% to 30.3%). The relapse-free survival curves did not differ significantly at any time during the trial period. In both treatment groups, three patients dropped out because of adverse effects. Four patients on sulfasalazine and six patients on olsalazine experienced minor adverse effects. One patient on sulfasalazine had mild leukopenia, and four patients on sulfasalazine and one patient on olsalazine had decreased levels of haptoglobin. Thus, sulfasalazine and olsalazine are equally effective in maintaining remission of ulcerative colitis and are accompanied by a similar incidence of adverse effects.

Adolescent↗
PubMed1992

A multicenter, double-blind, randomized, placebo-controlled comparison of nocturnal roxatidine in the treatment of active duodenal ulcer disease. Multicenter Roxatidine Cooperative Study Group.

This multicenter randomized, double-blind, 4-wk study compared the new H2-receptor antagonistic roxatidine (R) to placebo (P) for treatment of endoscopically diagnosed active duodenal ulcer disease. Subjects were evaluated after 2 and 4 wk of treatment. Those whose ulcer was unhealed at 2 wk received 2 more weeks of treatment before final evaluation. Ulcer healing (endoscopically determined) with roxatidine was more effective than placebo at both wk 0-2 (R = 33.9%, P = 21.9%, p = 0.018) and wk 2-4 (R = 68.2%, P = 29.7%, p less than 0.001), with an overall 4-wk effectiveness of 78.9% compared to 44.8% (p less than 0.001). At the end of treatment, average maximum ulcer diameter diminished 83% in R and 50% in P (p less than 0.001). Roxatidine was also more effective than placebo in decreasing abdominal pain (p less than 0.001), decreasing the number of antacid tablets taken for pain relief (p less than 0.001), improving dyspeptic symptoms (p less than 0.001), and permitting return to a normal routine for subjects with previous illness-imposed restrictions on work and/or other daily activities. The profile of laboratory values and adverse experiences demonstrated roxatidine to be safe and well-tolerated. The efficacy of roxatidine as evaluated by the healing rate of duodenal ulcer and reduction in abdominal pain emphasize its value as an addition to the family of H2-receptor antagonists.

Abdominal Pain↗
PubMed1995

[The effect of long-term monotherapy with preparations from the 4 basic groups of antihypertensive agents on the quality of life in patients with mild and moderate arterial hypertension. The Multicenter Captopril and the Quality of Life Study. The working group of the Multicenter Captopril and the Quality of Life Study].

A multicenter, controlled, open, randomized trial of antihypertensive and life quality (LQ) effects of monotherapy with captopril vs propranolol, hydrochlorothiazide and nifedipine included 345 males aged 35-60 years with mild and moderate hypertension. The results of 8-month treatment provided the conclusions: the drugs were much alike by antihypertensive efficacy, LQ parameters proved more beneficial in the group on captopril than those on nifedipine and propranolol, hydrochlorothiazide failed to improve life quality, captopril is an effective and safe antihypertensive drug superior to the drugs of 3 other antihypertensive drug groups by positively affecting LQ.

Adult↗
PubMed1995

[The long-term monotherapy with preparations from the 4 basic groups of antihypertensive agents of patients with mild and moderate arterial hypertension. The Multicenter Captopril and the Quality of Life Study. The working group of the Multicenter Captopril and the Quality of Life Study].

A multicenter randomized controlled trial was performed to compare antihypertensive effects and tolerance of captopril monotherapy with those of reference drugs from three other main groups of antihypertensive drugs: propranolol, hydrochlorothiazide, nifedipine. The trial included 345 males with essential hypertension stage I-II by WHO criteria. Evaluable patients after 8 months of treatment comprised 85.8%. 8-month monotherapy with captopril, nifedipine, hydrochlorothiazide and propranolol was completed by 53.49%, 75.28%, 45.78% of patients, respectively. An antihypertensive effect was reached in 57.97% of patients on monotherapy. Normalization of arterial pressure took place in 51.3%. The 4 drugs in the given doses produced a significant and similar effect in relation to the action on arterial pressure (absolute value). As for individual effects (complete and partial), captopril and propranolol were equal, nifedipine was more beneficial than hydrochlorothiazide. Side effects in captopril monotherapy arose 1.5-2 times less frequently than in response to propranolol or nifedipine and were similar to those of hydrochlorothiazide.

Adult↗
PubMed1996

Multicenter preoperative stroke risk index for patients undergoing coronary artery bypass graft surgery. Multicenter Study of Perioperative Ischemia (McSPI) Research Group.

BACKGROUND: The paradox of present cardiac surgery is that the more elderly and debilitated patients benefit most from cardiac surgery compared with medical therapy, yet they sustain greater overall risk for morbidity and mortality after cardiac surgery. The goal of the present study was to develop a preoperative index predicting major perioperative neurological events in patients undergoing coronary artery bypass graft surgery. METHODS AND RESULTS: As part of a prospective, multicenter, observational study (McSPI Research Group), we enrolled 2417 patients at 24 academic medical centers in the United States. Patients who died intraoperatively or had concomitant open-heart procedures were excluded from analysis, resulting in a total of 2107 for analysis. Sixty-eight patients (3.2%) developed adverse neurological events, defined as cerebrovascular accident, transient ischemic attack (TIA), or persistent coma. Bivariate analysis was applied to determine associations between preoperative variables and neurological events. Significant bivariate predictors were identified then logically grouped, and for each cluster, a score was calculated based on principal components. Key predictor variables were age, history of previous neurological disease, diabetes, history of vascular disease, previous coronary artery surgery, unstable angina, and history of pulmonary disease, the coefficients for which were used to develop a preoperative stroke risk index that was validated by bootstrap (c-index = 0.778). Stroke risk could then be determined for each patient, calculating a patient's risk for stroke within 95% confidence intervals. CONCLUSIONS: With the McSPI stroke risk index developed in this study, neurological risk can be estimated, and the most appropriate group for perioperative therapy can be identified. Further refinement and validation of this index, however, are necessary and are under way in current studies.

Adult↗
PubMed1996

[The Multicenter Captopril and the Quality of Life Study: the effect of antihypertensive agents from the basic groups on the quality of life of patients in different populations. The working group of the Multicenter Captopril and the Quality of Life Study].

This multicenter trial included 205 males aged 30-60 years with stable mild and moderate hypertension. 140 patients were from Moscow (140 patients), St. Petersburg, Kursk, Rostov (Russia); Kharkov, Donetsk (Ukraine); Baku (Azerbaijan). Group 1 patients received captopril, group 2 nifedipine, group 3 hydrochlorothiazide, group 4 propranolol.

Antihypertensive Agents↗
PubMed1998

Early detection of relapse by prospective reverse transcriptase-polymerase chain reaction analysis of the PML/RARalpha fusion gene in patients with acute promyelocytic leukemia enrolled in the GIMEMA-AIEOP multicenter "AIDA" trial. GIMEMA-AIEOP Multicenter "AIDA" Trial.

Although the majority of patients with acute promyelocytic leukemia (APL) are potentially cured by treatments combining all-trans retinoic acid (ATRA) and chemotherapy (CHT), a sizable proportion (around 30%) will relapse during follow-up. Retrospective molecular monitoring studies using reverse transcriptase-polymerase chain reaction (RT-PCR) for the specific PML/RARalpha fusion gene, have shown that a positive test usually precedes the occurrence of hematologic relapse. Prospective RT-PCR analyses were performed since 1993 at diagnosis and at preestablished time intervals during follow-up in bone marrow (BM) samples of 163 patients with PML/RARalpha+ APL enrolled in the multicenter Gruppo Italiano Malattie Ematologiche Maligne dell' Adulto (GIMEMA) trial AIDA (All-trans retinoic acid plus Idarubicin). Treatment consisted of ATRA and idarubicin for induction followed by three polychemotherapy courses as consolidation. The sensitivity level of the RT-PCR assay for PML/RARalpha, as assessed by serial dilution experiments, was 10(-4). All patients were in hematologic remission and tested PCR- at the end of consolidation. Of 21 who converted to PCR-positive thereafter, 20 underwent hematologic relapse at a median time of 3 months (range, 1 to 14) from the first PCR+ result. Seventeen of these 21 (81%) PCR+ conversions were recorded within the first 6 months postconsolidation. Of 142 who tested persistently PCR- in >/=2 tests after consolidation, 8 had hematologic relapse and 134 remained in complete remission (CR) after a median follow-up of 18 months (range, 6 to 38) postconsolidation. Using a time-dependent Cox model, the relative risk of hematologic relapse of patients who converted to PCR+ was 31.8 (confidence limits 95%, 12.9 to 78.3). Our results indicate that conversion to PCR positivity for PML/RARalpha during remission is highly predictive of subsequent hematologic relapse and highlight the prognostic value of stringent molecular monitoring during the early postconsolidation phase in APL. As a result of the present study, salvage treatment in patients enrolled in the GIMEMA trial AIDA is now anticipated at the time of molecular relapse, defined as the conversion to PCR positivity in two successive BM samplings during follow-up.

Adolescent↗
PubMed1984

Dihydroergotamine-heparin prophylaxis of postoperative deep vein thrombosis. A multicenter trial. The Multicenter Trial Committee.

In a large, prospective, multicenter investigation of the prophylaxis of deep vein thrombosis (DVT) in patients undergoing elective abdominal, pelvic, and thoracic surgery, 880 patients were randomized into five treatment groups: those receiving (1) dihydroergotamine mesylate, 0.5 mg, plus heparin sodium, 5,000 IU; (2) dihydroergotamine mesylate, 0.5 mg, plus heparin sodium, 2,500 IU; (3) heparin sodium, 5,000 IU alone; (4) dihydroergotamine mesylate, 0.5 mg alone; or (5) placebo. Treatment was initiated preoperatively and continued twice daily for five to seven days. Daily radiofibrinogen uptake tests revealed the following DVT rates: Dihydroergotamine mesylate, 0.5 mg, plus heparin sodium, 5,000 IU, 9.4%; dihydroergotamine mesylate, 0.5 mg, plus heparin sodium, 2,500 IU, 16.8%; heparin sodium, 5,000 IU alone, 16.8%; dihydroergotamine mesylate, 0.5 mg alone, 19.4%; and placebo, 24.4%. Dihydroergotamine mesylate, 0.5 mg, plus heparin sodium, 5,000 IU, was significantly superior to all other treatments. Adverse drug experiences did not differ significantly between groups and consisted primarily of postoperative bleeding (2% to 3%), injection site hematoma (6% to 12%), and wound hematoma (1% to 3%).

Adult↗
PubMed1985

Conference on insulin pump therapy in diabetes. Multicenter study of effect on microvascular disease. The Central Biochemistry Laboratory in the Multicenter Kroc Study. Problems and proposals.

The advantages of a multicenter trial can easily be lost if results from individual centers cannot be safely combined for statistical analysis. One objective of the Kroc Study was to develop methods that would allow valid amalgamation of results from laboratories at the six clinical centers and a central biochemical laboratory at the University of Newcastle upon Tyne. Responsibilities of the local laboratories, in addition to measurement of plasma glucose, creatinine, and glycosylated hemoglobin, were to obtain and prepare samples for measurement of plasma glucose, glycosylated hemoglobin, and serum lipids at the central laboratory, of C-peptide at the University of Chicago, and to collect and prepare samples for measurement of urinary albumin excretion at Guy's Hospital. The central laboratory was additionally to provide a system to ensure the comparability of plasma glucose determinations between and within centers, and to advise on common procedures for sample handling. Major problems were encountered with sample labeling, dispatch, and transport to the central laboratory. Although central determinations of plasma glucose and serum lipids were still possible in transported specimens, central assay of glycosylated hemoglobin proved inaccurate and useless. Compliance with the plasma glucose quality control program was variable among centers. Although the difference between the centers recording the highest and lowest values was 24.6% of the mean estimate of plasma glucose level, correlation between local and central plasma glucose determinations was good (r = 0.99, see pages 22-26).(ABSTRACT TRUNCATED AT 250 WORDS)

Blood Glucose↗
PubMed1986

World Health Organization multicenter study on menstrual and ovulatory patterns in adolescent girls. I. A multicenter cross-sectional study of menarche. World Health Organization Task Force on Adolescent Reproductive Health.

To study the maturation processes during puberty, the Task Force on Adolescent Reproductive Health of the World Health Organization implemented a multicenter study on the age of menarche. From seven centers in six countries, 3,073 girls between the ages of 11 and 15 years volunteered for a two-year study. The girls were questioned at entry as to whether they had menstruated; social background data were recorded, and height and weight were measured. The median age for menarche was calculated by a life-table technique. The median ages were: Hong Kong-12 years, 9 months; Geneva, Switzerland-13 years, 1 month; Zafed, Israel and Stockholm, Sweden-13 years, 3 months; urban Colombo, Sri Lanka-13 years, 6 months; Ile-Ife, Nigeria-13 years, 9 months; and rural Peradeniya, Sri Lanka-14 years, 5 months. Menarche of the rural Peradeniya girls was later than the urban girls from Colombo and other study centers. The mean heights, weights, and obesity indices (Quetelet's Index) were higher in postmenarcheal girls compared to premenarcheal girls for each age at all centers.

Actuarial Analysis↗
PubMed1989

Long-term safety and efficacy with Fibrel in the treatment of cutaneous scars--results of a multicenter study. Multicenter study group.

Three hundred patients were treated with Fibrel (Serono Laboratories, Randolph, MA) for the correction of cutaneous scars. Fibrel treatment was restricted to four scars with one or two treatments following a negative skin test. The scar corrections were evaluated by the physician, the patient, and also via an objective photogrammetric method. At the end of 1 year, the percentages of scars with moderate, marked, or complete correction were 65.0%, 63.3%, and 85.8% according to physician, patient, and photogrammetric evaluations, respectively. A cohort of 111 patients from the 1-year study were followed for up to 2 years postimplantation to evaluate safety and efficacy. These patients had similar demographic and scar characteristics as the total patient population in the initial study. The efficacy evaluation at the end of 24 months indicated that successful correction was maintained in 64.4%, 58.9%, and 78.9% of scars for physician, patient, and photogrammetric evaluations, respectively. There were no severe hypersensitivity reactions following treatment with Fibrel. The data from these patients demonstrate that one or two Fibrel treatments are effective in maintaining the correction of depressed cutaneous scars for up to 2 years with negligible adverse sequelae.

Adult↗
PubMed1989

Factors related to outcome in intensive care: French multicenter study. The French Multicenter Group of ICU Research; The Inserm Unit 169 of Statistical and Epidemiological Studies.

Four factors influence ICU outcome: age, previous health status (HS), severity of disease, and diagnosis. To assess the specific influence of each factor, 3,687 patients from 38 French ICUs were studied. For each patient, the following were noted: age, Simplified Acute Physiologic Score (SAPS), previous HS, diagnosis, ICU group (medical [M], surgical unscheduled [S], surgical scheduled or elective [E]), and the immediate outcome. The multivariate analysis ranks the factors in the following order: SAPS, age, ICU group, and previous HS. Diagnosis played a key role in prognosis, e.g., with SAPS score between 10 and 15 points, mortality was 0 for drug overdose, 12% for chronic obstructive pulmonary disease, and 38% for cardiac shock. For most patients, it was difficult to assign only one diagnosis; 37% were given one diagnosis, 39% two diagnoses, 17% three diagnoses, and 7% four and more diagnoses. Using ICU group instead of diagnosis, the mean death rate for groups M, S, and E was 20%, 27%, and 5%, respectively (p less than .001). Our study shows that each of the four factors influences the immediate outcome. It is thus possible to describe and classify ICU patients by this method, but the individual prognosis remains imprecise.

Age Factors↗
PubMed1989

Propranolol prevents first gastrointestinal bleeding in non-ascitic cirrhotic patients. Final report of a multicenter randomized trial. The Italian Multicenter Project for Propranolol in Prevention of Bleeding.

We report here the final analysis of a multicentre randomized, single-blind trial of propranolol for prophylaxis of first bleeding in cirrhosis. One hundred and seventy-four consecutive patients with large esophageal varices were randomly assigned to either propranolol in doses reducing the resting heart rate by 25% (85 patients) or to a placebo (vitamin K: 89 patients). Three were lost to follow-up and 26 had to be withdrawn from propranolol because of side effects (n = 23) or low compliance (n = 3). The cumulative value over 42 months of patients free of bleeding was 74% (95% confidence interval = 85%-63%) in the propranolol and 59% (95% CI = 79%-43%) in the control group and the corresponding survival figures were 51% (95% CI = 63%-39%) and 59% (95% CI = 75%-43%): neither of the differences was significant. A retrospective analysis according to the presence of ascites at randomization showed that in the subset without ascites the proportion of patients free of bleeding was significantly higher in the propranolol group than in the control group (83% vs. 61%; 95% CI = 97%-69% and 78%-44%, respectively; P = 0.028); this difference was even more evident in the ascites-free period (94% vs. 58%; 95% CI = 100%-86% and 76%-40%, respectively; P = 0.002). No differences were found in patients with ascites at randomization. Survival was not significantly affected by treatment in any subgroup, although it was shorter in the ascitic patients given propranolol than in controls (33% vs. 49%; 95% CI = 51%-15% and 71%-27%, respectively; P = 0.07).(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗