Clinical Trial: Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Extracorporeal Membrane Oxygenation(ECMO) for Severe Acute Respiratory Distress Syndrome (ARDS)
Brief Summary: This international multicenter, randomized, open trial will evaluate the impact of Extracorporeal Membrane Oxygenation (ECMO), instituted early after the diagnosis of acute respiratory distress syndrome (ARDS) not evolving favorably after 3-6 hours under optimal ventilatory management and maximum medical treatment, on the morbidity and mortality associated with this disease.
Detailed Summary:
Background: The acute respiratory distress syndrome (ARDS) is generally a severe pulmonary disease, whose associated mortality remains high. The most severe forms of ARDS, during which the hypoxemia induced by the lung involvement is the most profound, have an even more dismal prognosis, with a mortality rate exceeding 60%, despite resorting to exceptional adjunctive therapies, like NO inhalation, prone positioning of the patients, almitrine infusion or high frequency oscillation (HFO)-type ventilation. In these situations, certain teams propose establishing an extracorporeal circuit, combining a centrifuge pump and an oxygenator membrane, to assure total pulmonary assistance (oxygenation and CO2 removal from the blood), or Extra-Corporeal Membrane Oxygenation (ECMO). The aim of ECMO is to minimize the trauma induced by mechanical ventilation and to allow the lungs to rest. Unfortunately, trials evaluating ECMO for this indication over the past few decades were failures because of the interval between the onset of the disease and the installation of assistance, the poor oxygenation and CO2-removal capacities of the devices used, and the high rate of complications linked to the apparatus (massive hemorrhages resulting from intense anticoagulation and the poor 'biocompatibility' of the circuits). However, over the past few years, decisive progress has been made in the conception and construction of ECMO circuits, rendering them more 'biocompatible', better performing and more resistant. Finally, the results of the therapeutic trial (CESAR, UK) that used the latest generation ECMO are promising. Thus, the investigators now have strong clinical and pathophysiological rationales to evaluate, through a clinical trial with sufficient statistical power, the impact of early ECMO installation for the most severe forms of ARDS. This project integrates into a network (REVA or Network for Mechanical Ventilation) program.
Sponsor: Assistance Publique - Hôpitaux de Paris
Current Primary Outcome: All cause mortality on day 60 following randomization [ Time Frame: 60 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- mortality on day 30 in-ICU or in-hospital mortality [ Time Frame: 30 days ]
- mortality on day 90 in-ICU or in-hospital mortality [ Time Frame: 90 days ]
Original Secondary Outcome: Same as current
Information By: Assistance Publique - Hôpitaux de Paris
Dates:
Date Received: November 9, 2011
Date Started: October 2011
Date Completion: February 2018
Last Updated: March 21, 2017
Last Verified: December 2016
