Status:
COMPLETED
Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Maquet Cardiopulmonary GmbH
Conditions:
Acute Respiratory Distress Syndrome (ARDS)
Eligibility:
All Genders
18+ years
Phase:
NA
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 syndro...
Detailed Description
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 i...
Eligibility Criteria
Inclusion
- Inclusion criteria :
- ARDS defined according to the following criteria (9) :
- Intubation and mechanical ventilation for ≤ 6 days
- Bilateral radiological pulmonary infiltrates consistent with edema
- PaO2/FiO2 ratio \< 200 mm Hg
- Absence of clinical evidence of elevated left atrial pressure and/or pulmonary arterial occlusion pressure ≤ 18 mm Hg
- One of the 3 following criteria of disease severity:
- i. PaO2/FiO2 \< 50 mm Hg with FiO2 ≥ 80% for \> 3 hours, despite optimization of mechanical ventilation (Vt set at 6 ml/kg and trial of PEEP ≥ 10 cm H2O) and despite possible recourse to usual adjunctive therapies (NO, recruitment maneuvers, prone position, HFO ventilation, almitrine infusion) OR
- ii. PaO2/FiO2 \< 80 mm Hg with FiO2 ≥ 80% for \> 6 hours, despite optimization of mechanical ventilation (Vt set at 6 ml/kg and trial of PEEP ≥ 10 cm H2O) and despite possible recourse to usual adjunctive therapies (NO, recruitment maneuvers, prone position, HFO ventilation, almitrine infusion) OR
- iii. pH \< 7.25 (with PaCO2 ≥60 mm Hg) for \> 6 hours (with respiratory rate increased to 35/min) resulting from MV settings adjusted to keep plat ≤ 32 cm H2O (first, tidal volume reduction by steps of 1 mL/kg to 4 mL/kg then PEEP reduction to a minimum of 8 cm H2O.
- Obtain informed consent from a close relative or surrogate. Should such a person be absent, the patient will be randomized according to the specifications of emergency consent and the patient will be asked to give his/her consent for the continuation of the trial when his/her condition will allow.
- Exclusion criteria :
- Intubation and mechanical ventilation for ≥ 7 days
- Age \< 18 years
- Pregnancy
- Weight \> 1 kg/cm or BMI \> 45 kg/m²
- Chronic respiratory insufficiency treated with oxygen therapy of long duration and/or long-term respiratory assistance
- Cardiac failure requiring veno-arterial ECMO
- Previous history of heparin-induced thrombopenia
- Oncohaematological disease with fatal prognosis within 5 years
- Patient moribund on the day of randomization or has a SAPS II \> 90
- Non drug-induced coma following cardiac arrest
- Irreversible neurological pathology, for example, flat EEG tracing cerebral herniation…
- Decision to limit therapeutic interventions
- ECMO cannula access to femoral vein or jugular vein impossible.
- CardioHelp device not immediately available
Exclusion
Key Trial Info
Start Date :
December 8 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
249 Patients enrolled
Trial Details
Trial ID
NCT01470703
Start Date
December 8 2011
End Date
September 1 2017
Last Update
December 21 2018
Active Locations (1)
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1
Groupe Hospitalier Pitié Salpêtrière
Paris, France, 75013