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

December 16, 2025 updated by: Centre Hospitalier Universitaire Dijon

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

840

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France
        • CHU Dijon Bourgogne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient who has given free, written and informed consent
  • Patient of legal age.
  • Negative pregnancy test for women of childbearing age

  • Patient requiring cardiac surgery:

    • Scheduled (> 24h)
    • With extracorporeal circulation (ECC)
    • Myocardial revascularization (coronary bypass), and/or surgical correction of valvulopathy (aortic, mitral, pulmonary, tricupsidian), and/or of the ascending aorta and/or removal of an intracardiac tumor, and/or closure of a PFO/ASD

  • Patient with at least 3 risk factors for acute kidney failure including:

    • age > 70 years, combined surgery (more than two procedures), common trunk lesion, preoperative anemia, chronic respiratory failure, obliterative arterial disease of the lower extremities, diabetes, glomerular filtration < 60 ml min-1 m², LVEF <40%, redux, intra-aortic counterpulsation balloon, expected duration of bypass surgery > 100 min, albuminuria

Exclusion Criteria:

  • Patient not affiliated to national health insurance or not beneficiary of a social security system,
  • Patient subject to a measure of legal protection (curatorship, guardianship),
  • Pregnant, parturient or breastfeeding women,
  • Patients of legal age who are incapable or unable to express their consent,
  • Patients who have already been included in this study
  • Patients requiring emergency surgery (less than 24 hours)
  • Patient with chronic kidney failure on dialysis,
  • Patient with a cardiac transplant,
  • Patient on left-sided monoventricular assistance,
  • Patient on ECMO/ECLS,
  • Patient with acute circulatory failure in the immediate preoperative period (sepsis, hemorrhage),
  • Patients with known hypersensitivity to the active ingredient (argipressin) or to one of the excipients of REVERPLEG®.

Secondary exclusion criteria:

  • Patient not developing persistent arterial hypotension (vasoplegic syndrome), within 12 hours after completion of surgery, defined as persistent mean arterial pressure (MAP) <65 mmHg despite correction of preload and inotropism, with a cardiac index >2.2 l min-1 m-2, and not responding to 30 mg cumulative of ephedrine in bolus
  • Patient with hemorrhagic shock perioperatively before receiving vasopressor therapy (treatment under study)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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
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
Active Comparator: Control
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of a renal complication or death
Time Frame: From the onset of the vasoplegic syndrome until 7 days after
From the onset of the vasoplegic syndrome until 7 days after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2023

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

October 3, 2022

First Submitted That Met QC Criteria

October 3, 2022

First Posted (Actual)

October 5, 2022

Study Record Updates

Last Update Posted (Actual)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 16, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GUINOT PHRCI 2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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