Intensive care medicine · 1994
HA-1A in septic patients with ARDS: results from the pivotal trial.
Клиническое исследованиеСравнительное исследованиеСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Bigatello L M, Greene R E, Sprung C L, Panacek E A, Straube R C, Zimmerman J L, Maunder R J, Lanken P N, Pile-Spellmann E, Stanek K S
Аннотация
OBJECTIVE: To evaluate the effects of HA-1A, a human monoclonal antiendotoxin antibody, in septic patients with ARDS.
DESIGN: Substudy of a multicenter, double-blinded, placebo-controlled trial of HA-1A in septic patients.
PATIENTS: 63 septic patients with ARDS at the time of study entry.
INTERVENTION: A single intravenous injection of HA-1A (100 mg) or placebo.
RESULTS: A quantitative radiographic score, the PaO2/FIO2 ratio and an index of the severity of ARDS did not show a significant difference between the treatment and placebo groups at 3, 5 and 7 days after treatment. The duration of endotracheal intubation did not differ between the two groups. 15 of 30 HA-1A treated patients (50%) and 23 of 33 placebo-treated patients (69.7%) died within 28 days. The daily mortality was always lower in the HA-1A group, but this difference was not statistically significant at 28 days. The 28-day survival curves for the two treatment groups adjusted by covariate analysis were not significantly different (p = 0.07). Using logistic regression, a significant independent effect of HA-1A treatment was detected upon the early survival rate at 7 days (p = 0.03) but not at 14 and 28 days.
CONCLUSION: A single injection of HA-1A in septic patients with ARDS did not reverse acute respiratory failure or improve long-term survival.
DESIGN: Substudy of a multicenter, double-blinded, placebo-controlled trial of HA-1A in septic patients.
PATIENTS: 63 septic patients with ARDS at the time of study entry.
INTERVENTION: A single intravenous injection of HA-1A (100 mg) or placebo.
RESULTS: A quantitative radiographic score, the PaO2/FIO2 ratio and an index of the severity of ARDS did not show a significant difference between the treatment and placebo groups at 3, 5 and 7 days after treatment. The duration of endotracheal intubation did not differ between the two groups. 15 of 30 HA-1A treated patients (50%) and 23 of 33 placebo-treated patients (69.7%) died within 28 days. The daily mortality was always lower in the HA-1A group, but this difference was not statistically significant at 28 days. The 28-day survival curves for the two treatment groups adjusted by covariate analysis were not significantly different (p = 0.07). Using logistic regression, a significant independent effect of HA-1A treatment was detected upon the early survival rate at 7 days (p = 0.03) but not at 14 and 28 days.
CONCLUSION: A single injection of HA-1A in septic patients with ARDS did not reverse acute respiratory failure or improve long-term survival.