Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome (EOLIA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborator:
Maquet Cardiopulmonary AG
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01470703
First received: November 9, 2011
Last updated: November 12, 2013
Last verified: August 2012
  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.


Condition Intervention Phase
Acute Respiratory Distress Syndrome (ARDS)
Device: ECMO (Quadrox®, Jostra®, Maquet®)
Other: conventional care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Extracorporeal Membrane Oxygenation(ECMO) for Severe Acute Respiratory Distress Syndrome (ARDS)

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • All cause mortality on day 60 following randomization [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • mortality on day 30 in-ICU or in-hospital mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • mortality on day 90 in-ICU or in-hospital mortality [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 331
Study Start Date: October 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ECMO arm Device: ECMO (Quadrox®, Jostra®, Maquet®)
ECMO will be initiated as rapidly as possible by venovenous access. The material to be used consists of pre-heparinized cannulae and tubing, a centrifuge pump (CardioHelp®) and a heparinized membrane oxygenator (Quadrox®, Jostra®, Maquet®). To minimize the trauma induced by mechanical ventilation, the following ventilator settings will be used: volume-assist control mode, FiO2 30-60%, PEEP ≥10 cm H2O, VT lowered to obtain a plateau pressure <25 cm H2O, respiration rate (RR) 10-30/minute or APRV mode with high pressure level <25 cm H2O and low pressure level ≥10 cm H2O
Other Name: ECMO
Active Comparator: conventional arm Other: conventional care
Standard management of ARDS, according to the modalities applied by the 'maximal pulmonary recruitment' group in the EXPRESS trial (1): assist-controlled ventilatory mode, VT set at 6 ml/kg of ideal body weight and PEEP set so as not to exceed a plateau pressure of 28-30 cm H2O. In the case of refractory hypoxemia, the usual adjunctive therapeutics can be used: NO, prone position, HFO ventilation, almitrine infusion. A cross-over option to ECMO will be possible in the case of refractory hypoxemia defined as blood arterial saturation SaO2 <80% for >6 hours, despite mandatory use of recruitment maneuvers, and inhaled NO/prostacyclin and if technically possible a test of prone position, and only if the patient has no irreversible multiple organ failure and if the physician in charge of the patient believes that this could actually change the outcome

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  1. 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
  2. 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.

  3. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01470703

Locations
France
Groupe Hospitalier Pitié Salpêtrière Recruiting
Paris, France, 75013
Contact: Alain Combes, MD, PhD    +33142163818    alain.combes@psl.aphp.fr   
Principal Investigator: Alain Combes, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Maquet Cardiopulmonary AG
Investigators
Principal Investigator: Combes Alain, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01470703     History of Changes
Other Study ID Numbers: IDRCB 2009-A01026-51
Study First Received: November 9, 2011
Last Updated: November 12, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Acute Respiratory Distress Syndrome,
ECMO, Extracorporeal Membrane Oxygenation
Randomized controlled trial
Positive-Pressure ventilation
Survival Rate

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

ClinicalTrials.gov processed this record on July 28, 2014