HA-1A in septic patients with ARDS: results from the pivotal trial

• Published in: Intensive care medicine Vol. 20; no. 5; p. 328
• Main Authors: 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
• Format: Journal Article
• Language: English
• Published: United States 01.05.1994
• Subjects: Adult; Aged; Antibodies, Monoclonal - therapeutic use; Double-Blind Method; Endotoxins - immunology; Female; Humans; Immunoglobulin M - therapeutic use; Incidence; Lung - diagnostic imaging; Male; Middle Aged; Prospective Studies; Radiography; Respiratory Distress Syndrome, Adult - complications; Respiratory Distress Syndrome, Adult - diagnostic imaging; Respiratory Distress Syndrome, Adult - mortality; Respiratory Distress Syndrome, Adult - therapy; Risk Factors; Sepsis - complications; Sepsis - diagnostic imaging; Sepsis - mortality; Sepsis - therapy; Time Factors
• ISSN: 0342-4642
• DOI: 10.1007/BF01720904

To evaluate the effects of HA-1A, a human monoclonal antiendotoxin antibody, in septic patients with ARDS. Substudy of a multicenter, double-blinded, placebo-controlled trial of HA-1A in septic patients. 63 septic patients with ARDS at the time of study entry. A single intravenous injection of HA-1A (100 mg) or placebo. 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. A single injection of HA-1A in septic patients with ARDS did not reverse acute respiratory failure or improve long-term survival.