Search / Trial NCT00000572

Extracorporeal Carbon Dioxide Removal for Acute Respiratory Distress Syndrome

Launched by INTERMOUNTAIN HEALTH CARE, INC. · Oct 27, 1999

Trial Information

Current as of December 26, 2024

Completed

Keywords

ClinConnect Summary

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 (NHLBI) conducted the Extracorporeal Support for Respiratory Insufficiency (ECMO, Extracorporeal Membrane Oxygenation) 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 sup...

Gender

ALL

Eligibility criteria

  • Men and women with acute respiratory distress syndrome.
  • Inclusion Criteria: ECMO ENTRY CRITERIA (PaO2 \< 50 mm Hg -REPEATED THREE TIMES):
  • Rapid entry: 2 hours at fraFIO2=1.00 and PEEP\>5 cm H2O with PaCO2=30-45 mmHg
  • Slow entry: 12 hours at fraction of inspired oxygen (FIO2)\>0.60 and positive end-expiratory pressure (PEEP)\>5 cm H2O with PaCO2=30-45 mmHg and right to Left shunt fraction \>0.30
  • Exclusion Criteria:
  • 1. Contraindication to anti-coagulation (for example, gastrointestinal bleeding, recent cerebrovascular accident, or chronic bleeding disorder).
  • 2. Pw \> 25 mm Hg (superseded by our screening criterion that Pw \~ 15 mm Hg).
  • 3. Mechanical ventilation \>21. days.
  • 4. Severe chronic systemic disease or another clinical condition that, in itself,greatly limits survival; for example,
  • 1. Irreversible central nervous system disease
  • 2. Severe chronic pulmonary disease (forced expiratory volume in 1 second (FEV1)\<1 L, FEV1/FVC(forced vital capacity) \<0.3 of predicted, chronic PaCO2 \>45 mm Hg, chest x-ray evidence of overinflation or interstitial infiltration, or previous hospitalization for chronic respiratory insufficiency)
  • 3. Total-body surface burns\> 40%
  • 4. Rapidly fatal malignancy
  • 5. Chronic left ventricular failure
  • 6. Chronic renal failure (we required serum creatlnlne \~ 2 mg/dl or chronic dialysis therapy)
  • 7. Chronic liver failure (we required total serum bilirubin;?; 2 mg/dl)
  • 8. Immunosuppressed patients and patients with a positive human immu.. nodeficiency virus test

About Intermountain Health Care, Inc.

Intermountain Health Care, Inc. is a leading nonprofit healthcare system based in Salt Lake City, Utah, dedicated to improving community health through innovative clinical practices and rigorous research initiatives. With a commitment to evidence-based care and patient-centered approaches, Intermountain actively sponsors clinical trials that aim to advance medical knowledge and enhance treatment options across various health conditions. The organization leverages its extensive network of hospitals, outpatient facilities, and specialized care services to facilitate high-quality research while prioritizing patient safety and ethical standards. Through collaboration with healthcare professionals and academic institutions, Intermountain Health Care strives to contribute significantly to the advancement of healthcare practices and outcomes.

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Trial launched

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Estimated completion

Not reported

Discussion 0

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