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)

University Hospital Center (CHU) Dijon Bourgogne

Status and phase: Active, not recruiting; Phase 3

Conditions: Vasoplegic Syndrome; Scheduled Cardiac Surgery With Extracorporeal Circulation

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05568160

GUINOT PHRCI 2019

Details and patient eligibility

About

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.

Enrollment: 840 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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840 participants in 2 patient groups

Intervention

Experimental group

Treatment:

Other: Quality of Life Questionnaire EQ-5D

Other: Collection of clinical data

Drug: Vasopressin

Control

Active Comparator group

Treatment:

Other: Quality of Life Questionnaire EQ-5D

Drug: Norepinephrine

Other: Collection of clinical data