Back to results

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)

Primary Purpose

Scheduled Cardiac Surgery With Extracorporeal Circulation, Vasoplegic Syndrome

Status

Recruiting

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Vasopressin

Norepinephrine

Collection of clinical data

Quality of Life Questionnaire EQ-5D

About this trial

This is an interventional treatment trial for Scheduled Cardiac Surgery With Extracorporeal Circulation

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept 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 surgery, preoperative anemia, chronic respiratory failure, obliterative arterial disease of the lower extremities, diabetes, glomerular filtration < 60 ml min-1, LVEF <40%, redux, intra-aortic counterpulsation balloon, 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 postoperatively before receiving vasopressor therapy (treatment under study)

Sites / Locations

Chu Dijon BourgogneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Outcomes

Primary Outcome Measures

Occurrence of a renal complication or death

Secondary Outcome Measures

Full Information

NCT ID

NCT05568160

First Posted

October 3, 2022

Last Updated

September 7, 2023

Sponsor

Centre Hospitalier Universitaire Dijon

1. Study Identification

Unique Protocol Identification Number

NCT05568160

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 2, 2023 (Actual)

Primary Completion Date

March 2026 (Anticipated)

Study Completion Date

March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire Dijon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Scheduled Cardiac Surgery With Extracorporeal Circulation, Vasoplegic Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

840 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Title

Control

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Vasopressin

Intervention Description

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 Type

Drug

Intervention Name(s)

Norepinephrine

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Collection of clinical data

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Quality of Life Questionnaire EQ-5D

Intervention Description

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

Primary Outcome Measure Information:

Title

Occurrence of a renal complication or death

Time Frame

From the onset of the vasoplegic syndrome until 7 days after

10. Eligibility

Sex

All

Minimum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pierre-Grégoire GUINOT

Phone

0380281309

pierre-gregoire.guinot@chu-dijon.fr

Facility Information:

Facility Name

Chu Dijon Bourgogne

City

Dijon

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pierre-Grégoire GUINOT

Phone

0380281309

pierre-gregoire.guinot@chu-dijon.fr

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs