Clinical Trial Details

NCT ID: NCT01470703
Date Last Changed: September 25, 2017

Overview

Research Study Summary

A clinical trial to evaluate treatments using ECMO (Quadrox®, Jostra®, Maquet®) and conventional care for patients with Acute Respiratory Distress Syndrome (ARDS)

Research Study Title

Extracorporeal Membrane Oxygenation(ECMO) for Severe Acute Respiratory Distress Syndrome (ARDS)

Purpose

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.

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Recruitment Details

Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Duration
69 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

Inclusion criteria :

  1. ARDS defined according to the following criteria (9) :

  2. Intubation and mechanical ventilation for ≤ 6 days

  3. Bilateral radiological pulmonary infiltrates consistent with edema

  4. PaO2/FiO2 ratio < 200 mm Hg

  5. Absence of clinical evidence of elevated left atrial pressure and/or pulmonary arterial occlusion pressure ≤ 18 mm Hg

  6. 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 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.

  1. 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 :

  1. Intubation and mechanical ventilation for ≥ 7 days

  2. Age < 18 years

  3. Pregnancy

  4. Weight > 1 kg/cm or BMI > 45 kg/m²

  5. Chronic respiratory insufficiency treated with oxygen therapy of long duration and/or long-term respiratory assistance

  6. Cardiac failure requiring veno-arterial ECMO

  7. Previous history of heparin-induced thrombopenia

  8. Malignancy with fatal prognosis within 5 years

  9. Patient moribund on the day of randomization or has a SAPS II > 90

  10. Non drug-induced coma following cardiac arrest

  11. Irreversible neurological pathology, for example, flat EEG tracing cerebral herniation…

  12. Decision to limit therapeutic interventions

  13. ECMO cannula access to femoral vein or jugular vein impossible.

  14. CardioHelp device not immediately available

Site Locations (1)

Country State City Zip Facility and Contact
France Paris 75013 Groupe Hospitalier Pitié Salpêtrière
Alain Combes, MD, PhD
+33142163818
alain.combes@psl.aphp.fr

Alain Combes, MD, PhD
Principal Investigator

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