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NCT Number: 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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chu Dijon Bourgogne

Dijon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Vasopressin

Drug

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

norepinephrine

Drug

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

collection of clinical data

Other

At D1, D2, D7, D30 or D60 and D90

Quality of Life Questionnaire EQ-5D

Other

At the anesthesia consultation, discharge from intensive care, D7, D30 and D90

Primary outcomes

  1. Occurrence of a renal complication or death

    Time frame: From the onset of the vasoplegic syndrome until 7 days after

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

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

Acronym: NOVACC

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 5, 2022
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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