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Trial NCT00000562

Resource URI: http://static.linkedct.org/resource/trials/NCT00000562
linkedct:brief_title Extracorporeal Support for Respiratory Insufficiency (ECMO)
linkedct:condition <http://static.linkedct.org/resource/condition/360>
linkedct:condition <http://static.linkedct.org/resource/condition/7483>
linkedct:criteria Men and women, ages 12 to 65, not stratified as to ethnic group, who had potentially reversible acute respiratory failure.
linkedct:description 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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 65 Years
linkedct:eligibility_minimum_age 12 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000562
rdfs:label Trial NCT00000562
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000562
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 200
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/15208>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/22610>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/33904>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/4383>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/47168>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/50338>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/60841>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/928>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000562>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/42667>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date June 1974
linkedct:study_design Treatment, Randomized
linkedct:study_type Interventional
linkedct:summary 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.
rdf:type linkedct:trials
linkedct:verification_date January 2000