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Extracorporeal Carbon Dioxide Removal for Acute Respiratory Distress Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000572
First Posted: October 28, 1999
Last Update Posted: April 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Alan H. Morris, Intermountain Health Care, Inc.
  Purpose
To compare conventional therapy using low frequency positive pressure ventilation with extracorporeal CO2 removal for the treatment of adult respiratory distress syndrome (ARDS).

Condition Intervention Phase
Acute Respiratory Distress Syndrome Lung Diseases Procedure: positive-pressure ventilation Procedure: extracorporeal membrane oxygenation (CO2 removal) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extracorporeal Carbon Dioxide Removal for Acute Respiratory Distress Syndrome

Resource links provided by NLM:


Further study details as provided by Alan H. Morris, Intermountain Health Care, Inc.:

Primary Outcome Measures:
  • Survival [ Time Frame: Hospital stay (time until death): participants will be followed for the duration of hospital stay, an expected average of 30 days). ]
    All deaths occurred within 30 days of enrollment


Secondary Outcome Measures:
  • Hospital days [ Time Frame: up to hospital discharge ]
  • ICU days [ Time Frame: up to ICU discharge ]

Other Outcome Measures:
  • Hospital costs [ Time Frame: Hostpital stay ]
    $US

  • Bleeding/Hemorrhage [ Time Frame: Hospital stay ]
    Bleeding in ECCO2R subjects exceeded that in control subjects


Enrollment: 40
Study Start Date: June 1987
Study Completion Date: January 1993
Primary Completion Date: April 1991 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Extracorporeal membrane oxygenation (CO2 removal)
Detailed Electronic Protocol Controlled Extracorporeal CO2 Removal with reduced positive-pressure ventilation
Procedure: extracorporeal membrane oxygenation (CO2 removal)
Detailed computer protocol controlled Extracorporeal CO2 Removal with reduced positive pressure ventilation
Active Comparator: Protocol Controlled positive-pressure vent
Detailed Electronic Protocol Controlled positive-pressure ventilation
Procedure: positive-pressure ventilation
Detailed computer protocol controlled positive pressure ventilation

Detailed 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 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.

  Eligibility

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:

Responsible Party: Alan H. Morris, Professor, Director of Research, Pulmonary Division, Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT00000572     History of Changes
Other Study ID Numbers: 210
R01HL036787 ( U.S. NIH Grant/Contract )
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: April 10, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Syndrome
Lung Diseases
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Disease
Pathologic Processes
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury