Scheduled Cardiac Surgery With Extracorporeal CirculationPhase 3NOVACCNCT05568160
Evaluation of the Superiority of VAsopressin Versus NOradrenaline in the Management of Patients at Risk of Kidney Failure Undergoing Cardiac Surgery With Extracorporeal Circulation
A Phase 3 study testing Vasopressin, Norepinephrine and Collection of clinical data in people with Scheduled Cardiac Surgery With Extracorporeal Circulation and Vasoplegic Syndrome, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Scheduled Cardiac Surgery With Extracorporeal Circulation, Vasoplegic Syndrome
- What is being tested?
- Vasopressin, Norepinephrine and Collection of clinical data
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2023to Mar 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
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- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Vasopressin, Norepinephrine, Collection of clinical data, Quality of Life Questionnaire EQ-5D
- Medical subject headings
- Vasoplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VasopressinDrug
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
NorepinephrineDrug
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 dataOther
At D1, D2, D7, D30 or D60 and D90
Quality of Life Questionnaire EQ-5DOther
At the anesthesia consultation, discharge from intensive care, D7, D30 and D90
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Drug: Vasopressin; Other: Collection of clinical data; Other: Quality of Life Questionnaire EQ-5D |
| Control | Active comparator | Not described Receives: Drug: Norepinephrine; Other: Collection of clinical data; Other: Quality of Life Questionnaire EQ-5D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of a renal complication or death
Measured: From the onset of the vasoplegic syndrome until 7 days after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start2 Jan 2023
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Scheduled Cardiac Surgery With Extracorporeal CirculationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 840 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568160
- Sponsor's protocol ID
- GUINOT PHRCI 2019
- Acronym
- NOVACC
- Status last verified
- Dec 2025
- First submitted
- 3 Oct 2022
- Last updated
- 22 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38492626
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05568160
- Acronym / sponsor ID
- NOVACC / GUINOT PHRCI 2019
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 840 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 5 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- 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:
- Patient with at least 3 risk factors for acute kidney failure including:
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VasopressinThe 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 | Drug | Intervention |
| NorepinephrineThe 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 | Drug | Control |
| Collection of clinical dataAt D1, D2, D7, D30 or D60 and D90 | Other | Control, Intervention |
| Quality of Life Questionnaire EQ-5DAt the anesthesia consultation, discharge from intensive care, D7, D30 and D90 | Other | Control, Intervention |
Primary outcome
Occurrence of a renal complication or death
Time frame: From the onset of the vasoplegic syndrome until 7 days after
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Derived from this study: PubMed 38492626Guinot 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vasopressin, Norepinephrine and Collection of clinical data in people with Scheduled Cardiac Surgery With Extracorporeal Circulation and Vasoplegic Syndrome, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of a renal complication or death (time frame: From the onset of the vasoplegic syndrome until 7 days after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05568160, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.