NCT05568160

Evaluation of the Superiority of VAsopressin Versus NOradrenaline in the Management of Patients at Risk of Kidney Failure Undergoing Cardiac Surgery With Extracorporeal Circulation

Prospective Randomized Double-blind Study Evaluating the Superiority of VAsopressin Versus NOradrenaline in the Management of Patients at Risk of Kidney Failure Undergoing Cardiac Surgery With Extracorporeal Circulation

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 840 (estimated)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double blind, multicenter study following surgery with extracorporeal circulation to compare blood pressure optimization with vasopressin versus noradrenaline. It is planned to include 840 patients in order to have 420 patients with vasoplegic syndrome. The primary objective of this study is to determine whether the use of vasopressin to maintain blood pressure following cardiac surgery decreases the number of patients with acute renal failure and/or death compared with the usual use of norepinephrine. Participation in the study involves daily follow-up at D1, D2, and D7 of the onset of the syndrome and then follow-up at D30 and D90.

Conditions

• Scheduled Cardiac Surgery With Extracorporeal Circulation
• Vasoplegic Syndrome

Interventions

Type	Name	Description
DRUG	Vasopressin	The infusion is started at 5 ml hr-1, increased in increments of 1 ml hr-1 every 5 minutes to reach a maximum target rate of 30 ml hr-1
DRUG	Norepinephrine	The infusion is started at 5 ml h-1, increased in increments of 1 ml h-1 every 5 minutes to a maximum target rate of 30 ml h-1
OTHER	Collection of clinical data	At D1, D2, D7, D30 or D60 and D90
OTHER	Quality of Life Questionnaire EQ-5D	At the anesthesia consultation, discharge from intensive care, D7, D30 and D90

Timeline

• Start date: 2023-01-02
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2022-10-05
• Last updated: 2025-12-22

Locations

1 site across 1 country: France