Document Detail


Exogenous natural surfactant for treatment of acute lung injury and the acute respiratory distress syndrome.
MedLine Citation:
PMID:  19713451     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
RATIONALE: Compositional changes in surfactant and/or decreased surfactant content of the lungs are common features in patients with acute respiratory failure. Instillation of exogenous surfactant into the lungs of neonates with respiratory distress syndrome or pediatric patients with acute respiratory distress syndrome (ARDS) has resulted in improved survival. OBJECTIVES: We conducted this trial to determine whether the instillation of exogenous surfactant would improve the Day 28 outcome of adult patients with acute lung injury (ALI) or ARDS. METHODS: A total of 418 patients with ALI and ARDS were included in an international, multicenter, stratified, randomized, controlled, open, parallel-group study. We randomly assigned 418 patients to receive usual care either with or without instillation of exogenous natural porcine surfactant HL 10 as large boluses. MEASUREMENTS AND MAIN RESULTS: The primary endpoint was death rate before or on Day 28. Secondary endpoints were adverse event and death rate on day 180. The 28-day death rate in the usual care group was 24.5% compared with 28.8% in the HL 10 group. The estimated odds ratio for death at Day 28 in the usual care group versus the HL 10 group was 0.75 (95% CI, 0.48-1.18; P = 0.22). The most common adverse events related to HL 10 administration were temporary hypoxemia defined as oxygen saturation less than 88% (51.9% in HL 10 group vs. 25.2% in usual care) and hypotension defined as mean arterial blood pressure less than 60 mm Hg (34.1% in HL 10 group vs. 17.1% in usual care). CONCLUSIONS: In this study, instillation of a large bolus of exogenous natural porcine surfactant HL 10 into patients with acute lung injury and ARDS did not improve outcome and showed a trend toward increased mortality and adverse effects. Clinical trial registered with www.clinicaltrials.gov (NCT 00742482).
Authors:
Jozef Kesecioglu; Richard Beale; Thomas E Stewart; George P Findlay; Jean-Jacques Rouby; Laurent Holzapfel; Peter Bruins; Edmee J Steenken; Ole K Jeppesen; Burkhard Lachmann
Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2009-08-27
Journal Detail:
Title:  American journal of respiratory and critical care medicine     Volume:  180     ISSN:  1535-4970     ISO Abbreviation:  Am. J. Respir. Crit. Care Med.     Publication Date:  2009 Nov 
Date Detail:
Created Date:  2009-11-09     Completed Date:  2009-11-23     Revised Date:  2010-03-30    
Medline Journal Info:
Nlm Unique ID:  9421642     Medline TA:  Am J Respir Crit Care Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  989-94     Citation Subset:  AIM; IM    
Affiliation:
Department of Intensive Care Medicine, Q 04.460, University Medical Center Utrecht, P.O. Box 85500, 3508 GA, Utrecht, The Netherlands. j.kesecioglu@umcutrecht.nl
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00742482
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MeSH Terms
Descriptor/Qualifier:
Acute Lung Injury / drug therapy*,  mortality
Adolescent
Adult
Aged
Female
Humans
Male
Middle Aged
Pulmonary Surfactants / administration & dosage,  therapeutic use*
Respiratory Distress Syndrome, Adult / drug therapy*,  mortality
Chemical
Reg. No./Substance:
0/Pulmonary Surfactants
Comments/Corrections
Comment In:
Am J Respir Crit Care Med. 2010 Apr 1;181(7):762; author reply 762-3   [PMID:  20335386 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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