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Extracorporeal Support for Respiratory Insufficiency (ECMO)

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ClinicalTrials.gov Identifier: NCT00000562
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : November 26, 2013
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

October 27, 1999
October 28, 1999
November 26, 2013
June 1974
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Complete list of historical versions of study NCT00000562 on ClinicalTrials.gov Archive Site
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Extracorporeal Support for Respiratory Insufficiency (ECMO)
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To evaluate indications for the use and efficacy of extracorporeal membrane oxygenators (ECMO's) for the support of patients with potentially reversible acute respiratory failure.

BACKGROUND:

The report of the Task Force on Respiratory Diseases identified a clinical syndrome of acute respiratory insufficiency (ARI) and estimated that approximately 60,000 Americans die of ARI yearly. ARI was not precisely defined; indeed, the Task Force realized that pathologists do not recognize ARI. The Task Force pointed out that no diagnostic tests for early detection of ARI exist, that the incidence and prevalence of the disease are not known, and that existing therapy is supportive and nonspecific (diuretics, corticosteroids, etc.). The pathogenesis of the syndrome, the mechanism of interstitial edema, the defenses of the lung against agents causing ARI, and the ultrastructural pathology and natural history of the disease were virtually unknown. The Task Force indicated a need for Respiratory Care Centers with highly trained personnel that could reduce mortality from ARI.

This clinical trial grew out of the Task Force report. Nine participating centers defined ARI in clinical and physiological terms and agreed to a prospective randomized study for 3 years to compare treatment of severe ARI by conventional means with treatment by extracorporeal membrane oxygenators.

Animal studies have shown that ECMO's can provide one to two weeks' support for the lungs without serious blood damage, in contrast to bubble oxygenators, which allow complete pulmonary bypass for approximately 6 hours, after which severe blood damage occurs at the direct blood-gas interface. If patients with hypoxia secondary to acute reversible lung injury can be supported with ECMO's until the lung lesion heals, improvement in survival rates and avoidance of the hazards of conventional therapy may result. The trial, now completed, was conducted at nine clinical centers in the United States.

DESIGN NARRATIVE:

Randomized, non-blind, fixed sample; 90 eligible patients were randomly assigned to a group receiving extracorporeal membrane oxygenation plus conventional therapy or to a group receiving conventional therapy.

The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
  • Acute Respiratory Failure
  • Lung Diseases
Procedure: extracorporeal membrane oxygenation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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November 1979
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Men and women, ages 12 to 65, not stratified as to ethnic group, who had potentially reversible acute respiratory failure.
Sexes Eligible for Study: All
12 Years to 65 Years   (Child, Adult, Older Adult)
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Contact information is only displayed when the study is recruiting subjects
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NCT00000562
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R01HL016154-05 ( Other Grant/Funding Number: US NIH Grant Number )
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National Heart, Lung, and Blood Institute (NHLBI)
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Investigator: Robert Bartlett University of California, Irvine
Investigator: Philip Drinker Brigham and Women's Hospital
Investigator: L. Edmunds University of Pennsylvania
Investigator: Alan Morris University of Utah
Investigator: E. Pierce Icahn School of Medicine at Mount Sinai
Investigator: Herbert Proctor University of North Carolina
Investigator: Arthur Thomas University of California
Investigator: Warren Zapol Massachusetts General Hospital
National Heart, Lung, and Blood Institute (NHLBI)
January 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP