Search / Trial NCT00000572

Extracorporeal Carbon Dioxide Removal for Acute Respiratory Distress Syndrome

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

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Trial Information

Current as of May 23, 2024

Completed

Keywords

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 (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:
  • Contraindication to anti-coagulation (for example, gastrointestinal bleeding, recent cerebrovascular accident, or chronic bleeding disorder).
  • Pw > 25 mm Hg (superseded by our screening criterion that Pw ~ 15 mm Hg).
  • Mechanical ventilation >21. days.
  • Severe chronic systemic disease or another clinical condition that, in itself,greatly limits survival; for example,
  • Irreversible central nervous system disease
  • 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)
  • Total-body surface burns> 40%
  • Rapidly fatal malignancy
  • Chronic left ventricular failure
  • Chronic renal failure (we required serum creatlnlne ~ 2 mg/dl or chronic dialysis therapy)
  • Chronic liver failure (we required total serum bilirubin;?; 2 mg/dl)
  • Immunosuppressed patients and patients with a positive human immu.. nodeficiency virus test

Attachments

readout_NCT00000572_2024-05-23.pdf

4.5 MB

NCT00000572_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Hospital stay (time until death): participants will be followed for the duration of hospital stay, an expected average of 30 days).

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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