Veno-arterial Extracorporeal Membrane Oxygenation to Reduce Morbidity and Mortality Following Lung Transplant: a Randomized Controlled Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

In patients undergoing lung transplantation (LT), the investigators hypothesize that a systematic intraoperative ECMO strategy would reduce the need for invasive mechanical ventilation in the first 28 days without increasing adverse events, as compared to an on-demand intraoperative ECMO strategy. To date, LT remains a highly hazardous procedure. Even if the surgical procedure is well established, the intraoperative support is not, and most intra-operative ECMO decisions rely on local protocols, anesthesiologists' habits, and surgeons' preference. The efficacy of applying a systematic strategy on reducing the occurrence of severe primary graft dysfunction and thus mechanical ventilation in the 28 days following LT, without increasing mortality or morbidity, would support future guidelines on the use of ECMO in the intraoperative period of LT for obstructive and restrictive lung diseases.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \>18 years Assessed for bilateral sequential lung transplantation for obstructive or restrictive lung disease Affiliation to the French social security Written informed consent

Locations
Other Locations
France
Hôpital Bichat Claude Bernard
RECRUITING
Paris
Hôpital FOCH
NOT_YET_RECRUITING
Suresnes
Contact Information
Primary
Jonathan MESSIKA, MD
j.messika@hopital-foch.com
+33 1 46 25 59 84
Time Frame
Start Date: 2024-02-29
Estimated Completion Date: 2027-09-28
Participants
Target number of participants: 200
Treatments
Experimental: Systematic ECMO
VA-ECMO will be implanted before the first pulmonary artery cross-clamp, in a systematic manner
Active_comparator: On-demand ECMO
VA-ECMO will be implanted intraoperatively, in an unplanned manner if the hemodynamic and respiratory indices meet pre-planned criteria at different time-points:~a PaO2/FiO2 ratio\<100 mmHg or a respiratory acidosis, with pH\< 7.2, PaCO2\>60 mmHg, a mean pulmonary arterial pressure\>50mmHg (or 2/3 of MAP) and/or an acute pulmonal core at trans-esophageal echography monitoring an acute left ventricular dysfunction at trans-esophageal echography monitoring
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov