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

Vasoplegic Syndrome Clinical Trial

— NOVACC  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05568160
• Other study ID #: GUINOT PHRCI 2019
• Status: Recruiting
• Phase: Phase 3
• Start date: January 2, 2023
• Est. completion date: March 2026

Study information

• Verified date: September 2023
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Pierre-Grégoire GUINOT
• Phone: 0380281309
• Email: pierre-gregoire.guinot[@]chu-dijon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 840
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Renal Insufficiency
• Vasoplegia
• Vasoplegic Syndrome

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
• 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
• Quality of Life Questionnaire EQ-5D
At the anesthesia consultation, discharge from intensive care, D7, D30 and D90

Locations

Country	Name	City	State
France	Chu Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of a renal complication or death		From the onset of the vasoplegic syndrome until 7 days after