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

NCT05568160 | Active Not Recruiting Phase 3

• 1 other identifier: GUINOT PHRCI 2019
• Study Type: interventional
• Target: 840
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Occurrence of a renal complication or death

  From the onset of the vasoplegic syndrome until 7 days after

Study Arms (2)

Intervention

EXPERIMENTAL

Drug: Vasopressin; Other: Collection of clinical data; Other: Quality of Life Questionnaire EQ-5D

Control

ACTIVE COMPARATOR

Drug: Norepinephrine; Other: Collection of clinical data; Other: Quality of Life Questionnaire EQ-5D

Interventions

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

Intervention

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

Control

Collection of clinical data OTHER

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

Control; Intervention

Quality of Life Questionnaire EQ-5D OTHER

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

Control; Intervention

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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®.
• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, France

Location

Related Publications (1)

• Guinot PG, Desebbe O, Besch G, Guerci P, Gaudard P, Lena D, Mertes PM, Abou-Arab O, Bouhemad B; NOVACC study group. Prospective randomized double-blind study to evaluate the superiority of Vasopressin versus Norepinephrine in the management of the patient at renal risk undergoing cardiac surgery with cardiopulmonary bypass (NOVACC trial). Am Heart J. 2024 Jun;272:86-95. doi: 10.1016/j.ahj.2024.03.008. Epub 2024 Mar 16.

  PMID: 38492626 DERIVED

MeSH Terms

Conditions

Vasoplegia

Interventions

Vasopressins; Norepinephrine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 5, 2022
• Study Start: January 2, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

FR (1)