Acute Respiratory Distress Syndrome Clinical Trial
Official title:
Extracorporeal Carbon Dioxide Removal for Acute Respiratory Distress Syndrome
Verified date | March 2018 |
Source | Intermountain Health Care, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To compare conventional therapy using low frequency positive pressure ventilation with extracorporeal CO2 removal for the treatment of adult respiratory distress syndrome (ARDS).
Status | Completed |
Enrollment | 40 |
Est. completion date | January 1993 |
Est. primary completion date | April 1991 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 25 mm Hg (superseded by our screening criterion that Pw ~ 15 mm Hg). 3.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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Intermountain Health Care, Inc. | National Heart, Lung, and Blood Institute (NHLBI) |
Brunet F, Mira JP, Dhainaut JF, Dall'ava-Santucci J. Efficacy of low-frequency positive-pressure ventilation-extracorporeal CO2 removal. Am J Respir Crit Care Med. 1995 Apr;151(4):1269-70. — View Citation
East TD, Böhm SH, Wallace CJ, Clemmer TP, Weaver LK, Orme JF Jr, Morris AH. A successful computerized protocol for clinical management of pressure control inverse ratio ventilation in ARDS patients. Chest. 1992 Mar;101(3):697-710. — View Citation
East TD, Morris AH, Wallace CJ, Clemmer TP, Orme JF Jr, Weaver LK, Henderson S, Sittig DF. A strategy for development of computerized critical care decision support systems. Int J Clin Monit Comput. 1991-1992;8(4):263-9. — View Citation
Falke KJ. Randomized clinical trial of pressure-controlled inverse ratio ventilation and extracorporeal CO2 removal for adult respiratory distress syndrome. Am J Respir Crit Care Med. 1997 Sep;156(3 Pt 1):1016-7. — View Citation
Habashi NM, Reynolds HN, Borg U, Cowley RA. Randomized clinical trial of pressure-controlled inverse ration ventilation and extra corporeal CO2 removal for ARDS. Am J Respir Crit Care Med. 1995 Jan;151(1):255-6. — View Citation
Henderson S, Crapo RO, Wallace CJ, East TD, Morris AH, Gardner RM. Performance of computerized protocols for the management of arterial oxygenation in an intensive care unit. Int J Clin Monit Comput. 1991-1992;8(4):271-80. — View Citation
Morris AH, East TD, Wallace CJ, Orme J Jr, Clemmer T, Weaver L, Thomas F, Dean N, Pearl J, Rasmusson B. Ethical implications of standardization of ICU care with computerized protocols. Proc Annu Symp Comput Appl Med Care. 1994:501-5. — View Citation
Morris AH, Menlove RL, Rollins RJ, Wallace CJ, Beck E. A controlled clinical trial of a new 3-step therapy that includes extracorporeal CO2 removal for ARDS. ASAIO Trans. 1988 Jan-Mar;34(1):48-53. — View Citation
Morris AH, Wallace CJ, Menlove RL, Clemmer TP, Orme JF Jr, Weaver LK, Dean NC, Thomas F, East TD, Pace NL, Suchyta MR, Beck E, Bombino M, Sittig DF, Böhm S, Hoffmann B, Becks H, Butler S, Pearl J, Rasmusson B. Randomized clinical trial of pressure-control — View Citation
Morris AH. Adult respiratory distress syndrome and new modes of mechanical ventilation: reducing the complications of high volume and high pressure. New Horiz. 1994 Feb;2(1):19-33. Review. — View Citation
Morris AH. Protocol management of adult respiratory distress syndrome. New Horiz. 1993 Nov;1(4):593-602. Review. Erratum in: New Horiz 1994 Feb;2(1):7. — View Citation
Morris AH. Uncertainty in the management of ARDS: lessons for the evaluation of a new therapy. Intensive Care Med. 1994;20(2):87-9. — View Citation
Sittig DF, Gardner RM, Morris AH, Wallace CJ. Clinical evaluation of computer-based respiratory care algorithms. Int J Clin Monit Comput. 1990 Jul;7(3):177-85. — View Citation
Sittig DF, Gardner RM, Pace NL, Morris AH, Beck E. Computerized management of patient care in a complex, controlled clinical trial in the intensive care unit. Comput Methods Programs Biomed. 1989 Oct-Nov;30(2-3):77-84. — View Citation
Sittig DF, Pace NL, Gardner RM, Beck E, Morris AH. Implementation of a computerized patient advice system using the HELP clinical information system. Comput Biomed Res. 1989 Oct;22(5):474-87. — View Citation
Suchyta MR, Clemmer TP, Elliott CG, Orme JF Jr, Weaver LK. The adult respiratory distress syndrome. A report of survival and modifying factors. Chest. 1992 Apr;101(4):1074-9. — View Citation
Suchyta MR, Clemmer TP, Orme JF Jr, Morris AH, Elliott CG. Increased survival of ARDS patients with severe hypoxemia (ECMO criteria). Chest. 1991 Apr;99(4):951-5. — View Citation
Suchyta MR, Elliott CG, Colby T, Rasmusson BY, Morris AH, Jensen RL. Open lung biopsy does not correlate with pulmonary function after the adult respiratory distress syndrome. Chest. 1991 May;99(5):1232-7. — View Citation
Suchyta MR, Elliott CG, Jensen RL, Crapo RO. Predicting the presence of pulmonary function impairment in adult respiratory distress syndrome survivors. Respiration. 1993;60(2):103-8. — View Citation
* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Hospital costs | $US | Hospital stay | |
Other | Bleeding/Hemorrhage | Bleeding in ECCO2R subjects exceeded that in control subjects | Hospital stay | |
Primary | Survival | All deaths occurred within 30 days of enrollment | Hospital stay (time until death): participants will be followed for the duration of hospital stay, an expected average of 30 days). | |
Secondary | Hospital days | up to hospital discharge, approximately 30 days | ||
Secondary | ICU days | up to ICU discharge, approximately 30 days |
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