Last updated: February 28, 2023
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Completed
Phase
N/A
Condition
Lung Injury
Acute Respiratory Distress Syndrome (Ards)
Respiratory Failure
Treatment
N/AClinical Study ID
NCT04607551
APHP180607
2019-A02669-48
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Severe ARDS refractory to conventional therapy placed on VV-ECMO support in thepreceding 48h.
- Obtain informed consent from a close relative or surrogate. According to thespecifications of emergency consent, randomization without the close relative orsurrogate consent could be performed. Close relative/surrogate/family consent will be asked as soon as possible. The patientwill be asked to give his/her consent for the continuation of the trial when his/hercondition will allow.
- Social security registration
Exclusion
Exclusion Criteria:
- Age <18 and >75
- Pregnancy and breastfeeding woman
- Initiation of VV-ECMO >48 h
- Resuscitation >10 minutes before ECMO
- Irreversible neurological pathology
- End-stage chronic lung disease
- ARDS secondary to an abdominal surgery
- Contraindications for PP
- Irreversible ARDS with no hope for lung function recovery
- Patient moribund on the day of randomization, SAPS II >90
- Liver cirrhosis (Child B or C)
- Chronic renal failure requiring hemodialysis
- Lung transplantation
- Burns on more than 20 % of the body surface
Study Design
Total Participants: 170
Study Start date:
March 03, 2021
Estimated Completion Date:
December 31, 2022
Connect with a study center
Hôpital Pitié Salpêtrière
Paris, 75013
FranceSite Not Available

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