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Trial NCT00000572

Resource URI: http://static.linkedct.org/resource/trials/NCT00000572
PropertyValue
linkedct:brief_title Extracorporeal Carbon Dioxide Removal for Adult Respiratory Distress Syndrome
linkedct:condition <http://static.linkedct.org/resource/condition/359>
linkedct:condition <http://static.linkedct.org/resource/condition/7483>
linkedct:criteria Men and women with adult respiratory distress syndrome.
linkedct:description BACKGROUND: It is estimated that at least 150,000 individuals die each year of adult respiratory distress syndrome. Treatment remains largely supportive. The National Heart, Lung, and Blood Institute conducted the Extracorporeal Support for Respiratory Insufficiency (ECMO) trial from June 1974 through 1978. In ECMO, 90 patients were randomized to either extracorporeal membrane oxygenation plus conventional therapy or to conventional therapy. Survival rates were less than ten percent in both groups. The failure of the trial to demonstrate the superiority of ECMO over conventional ventilatory support resulted in the virtual elimination of the use of ECMO in clinical medicine. In the earlier NHLBI trial, ECMO was implemented with a veno-arterial shunt which approximated 90 percent of the baseline cardiac output. Ventilation of the lungs was continued with reduced function of inspiration oxygen. Thus, the lungs were deprived of the principle source of blood supply while continuously exposed to potentially injurious ventilatory pressures and gas composition. The present patient trial used a new form of therapy developed by Dr. Gattinoni and co-workers in Milan, Italy with the collaboration of Dr. Kolobow at the National Institutes of Health in Bethesda. The authors reported a 77 percent survival rate for the new therapy. In Step 1 of the new therapy, the patient was initially ventilated with pressure-controlled, inverted ratio ventilation. If the patient did not improve, Step 2 using extracorporeal perfusion was performed with a veno-venous shunt in contrast to a veno-arterial shunt. The veno-venous shunt preserved pulmonary blood flow whereas the veno-arterial shunt diminished it. Step 3 was reserved for those patients who did not meet the therapeutic criteria of Step 2. They underwent low frequency positive-pressure ventilation and extracorporeal CO2 removal involving veno-venous bypass via the internal jugular and femoral or bilateral saphenous veins. DESIGN NARRATIVE: Randomized, fixed sample. Patients were stratified by age (under and over 40 years) and by the presence or absence of trauma. Patients were assigned to conventional positive pressure ventilation therapy or to a three-step therapeutic program employing pressure-controlled-inverted-ratio-ventilation, continuous positive airway pressure, and low-frequency positive pressure ventilation-extracorporeal CO2 removal. The main outcome measure was survival at 30 days after randomization. Secondary outcome measures included hospital costs, physiologic data, length of hospital stay, and blood product consumption. Follow-up took place during the year after hospital discharge.
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 75 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000572
rdfs:label Trial NCT00000572
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000572
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 210
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000572>
linkedct:phase Phase 2
linkedct:reference <http://static.linkedct.org/resource/reference/23883>
linkedct:reference <http://static.linkedct.org/resource/reference/24620>
linkedct:reference <http://static.linkedct.org/resource/reference/35639>
linkedct:reference <http://static.linkedct.org/resource/reference/35640>
linkedct:reference <http://static.linkedct.org/resource/reference/37903>
linkedct:reference <http://static.linkedct.org/resource/reference/37937>
linkedct:reference <http://static.linkedct.org/resource/reference/38623>
linkedct:reference <http://static.linkedct.org/resource/reference/39602>
linkedct:reference <http://static.linkedct.org/resource/reference/39807>
linkedct:reference <http://static.linkedct.org/resource/reference/40424>
linkedct:reference <http://static.linkedct.org/resource/reference/46738>
linkedct:reference <http://static.linkedct.org/resource/reference/46861>
linkedct:reference <http://static.linkedct.org/resource/reference/47393>
linkedct:reference <http://static.linkedct.org/resource/reference/47877>
linkedct:reference <http://static.linkedct.org/resource/reference/48280>
linkedct:reference <http://static.linkedct.org/resource/reference/48434>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date June 1987
linkedct:study_design Treatment, Randomized
linkedct:study_type Interventional
linkedct:summary To compare conventional therapy using low frequency positive pressure ventilation with extracorporeal CO2 removal for the treatment of adult respiratory distress syndrome (ARDS).
rdf:type linkedct:trials
linkedct:verification_date January 2000