Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome

NCT01470703 | Completed DMC

• 2 other identifiers: P0812242009-A01026-51
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Keywords

Acute Respiratory Distress Syndrome,; ECMO, Extracorporeal Membrane Oxygenation; Randomized controlled trial; Positive-Pressure ventilation; Survival Rate

Outcome Measures

Primary Outcomes (1)

• All cause mortality on day 60 following randomization

  60 days

Secondary Outcomes (4)

• mortality on day 30 in-ICU or in-hospital mortality

  30 days

• mortality on day 90 in-ICU or in-hospital mortality

  90 days

• Mortality in-ICU or in-hospital mortality

  at days 30, 60 and 90

• Mortality in-ICU or in-hospital mortality

  at days 30, 60 and 90

Study Arms (2)

ECMO arm

EXPERIMENTAL

Device: ECMO (Quadrox®, Jostra®, Maquet®)

conventional arm

ACTIVE COMPARATOR

Other: conventional care

Interventions

ECMO (Quadrox®, Jostra®, Maquet®) DEVICE

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

Also known as: ECMO

ECMO arm

conventional care OTHER

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

conventional arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Maquet Cardiopulmonary GmbH: collaborator

Study Sites (1)

Groupe Hospitalier Pitié Salpêtrière

Paris, 75013, France

Location

Related Publications (4)

• Combes A, Hajage D, Capellier G, Demoule A, Lavoue S, Guervilly C, Da Silva D, Zafrani L, Tirot P, Veber B, Maury E, Levy B, Cohen Y, Richard C, Kalfon P, Bouadma L, Mehdaoui H, Beduneau G, Lebreton G, Brochard L, Ferguson ND, Fan E, Slutsky AS, Brodie D, Mercat A; EOLIA Trial Group, REVA, and ECMONet. Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome. N Engl J Med. 2018 May 24;378(21):1965-1975. doi: 10.1056/NEJMoa1800385.

  PMID: 29791822 BACKGROUND

• Schmidt M, Combes A. Influence of ventilatory strategy on the PRESERVE mortality risk score: response to Camporota et al. Intensive Care Med. 2014 Jun;40(6):916. doi: 10.1007/s00134-014-3284-x. Epub 2014 Apr 10. No abstract available.

  PMID: 24718643 DERIVED

• Schmidt M, Pellegrino V, Combes A, Scheinkestel C, Cooper DJ, Hodgson C. Mechanical ventilation during extracorporeal membrane oxygenation. Crit Care. 2014 Jan 21;18(1):203. doi: 10.1186/cc13702.

  PMID: 24447458 DERIVED

• Schmidt M, Zogheib E, Roze H, Repesse X, Lebreton G, Luyt CE, Trouillet JL, Brechot N, Nieszkowska A, Dupont H, Ouattara A, Leprince P, Chastre J, Combes A. The PRESERVE mortality risk score and analysis of long-term outcomes after extracorporeal membrane oxygenation for severe acute respiratory distress syndrome. Intensive Care Med. 2013 Oct;39(10):1704-13. doi: 10.1007/s00134-013-3037-2. Epub 2013 Aug 2.

  PMID: 23907497 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Extracorporeal Membrane Oxygenation

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Combes Alain, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: November 11, 2011
• Study Start: December 8, 2011
• Primary Completion: July 1, 2017
• Study Completion: September 1, 2017
• Last Updated: December 21, 2018

Record last verified: 2017-09

Locations

FR (1)