Showing papers by "Robert A. Balk published in 1997"

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

Abstract: Objective: To determine the therapeutic efficacy and safety of recombinant human interleukin-1 receptor antagonist (rhlL-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 rhlL-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 rhlL-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 rhlL-1ra treatment in this study. Conclusions: A 72-hr, continuous intravenous infusion of rhlL-1ra failed to demonstrate a statistically significant reduction in mortality when compared with standard therapy in this multicenter clinical trial. If rhlL-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.

Radiographic patterns of pulmonary disease.

Abstract: Pulmonary radiographs are essential adjuncts to the evaluation and diagnosis of suspected pulmonary disease. In the intensive care unit, radiographs are useful to confirm correct positioning of diagnostic and therapeutic devices. Patterns seen on the radiograph may be within broadly normal limits or may be interpreted as abnormal, especially when placed in the clinical context of a specific patient's problem. The description abnormal can be related to both nonspecific and specific radiographic patterns of disease. Nonspecific radiographic patterns of disease include location of disease, temporal course of disease, pleural abnormalities, hyperinflation, extra-alveolar air, atelectasis, bronchiectasis, and vascular disease. Specific radiographic patterns of disease are discrete anatomic structures seen on a radiograph, for example, cavitary and cystic disease. The interpretation of nonspecific and specific radiographic patterns is useful in diagnosis, selection of treatment, and monitoring of the course of disease and the patient's response to treatment.