Evaluating the superiority of VAsopressin versus NOradrenaline in the management of the renal risk patient undergoing cardiac surgery with extracorporeal circulation

Phase 3

Recruiting

Conditions: vasoplegic syndrome

Registration Number: 2022-500419-38-00

Lead Sponsor: Centre Hospitalier Universitaire Dijon Bourgogne

Brief Summary: To compare 2 blood pressure optimization strategies (vasopressin versus norepinephrine) on the occurrence of a composite end point combining renal complications and death at D7 of the onset of vasoplegic syndrome in patients undergoing cardiac surgery with extracorporeal circulation.

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing, recruiting

Sex: Not specified

Target Recruitment: 840

Inclusion Criteria

Patient who has given free, written and informed consent

Patient of legal age

Patient requiring cardiac surgery: o Scheduled (> 24h) o With extracorporeal circulation (ECC) o 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, LVEF <40%, redux, intra-aortic counterpulsation balloon, expected duration of bypass surgery > 100 min, albuminuria

Negative pregnancy test for women of childbearing age

Exclusion Criteria

Patient not affiliated to national health insurance or not beneficiary of a social security system

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 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

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of a renal complication or death from the onset of vasoplegic syndrome until 7 days after. Renal complications are defined as the occurrence of acute kidney failure as defined by the KDIGO definition (stage 1 or higher), and/or the initiation of renal replacement therapy		Occurrence of a renal complication or death from the onset of vasoplegic syndrome until 7 days after. Renal complications are defined as the occurrence of acute kidney failure as defined by the KDIGO definition (stage 1 or higher), and/or the initiation of renal replacement therapy

Secondary Outcome Measures

Name	Time	Method
The occurrence of a renal complication (as defined in the primary endpoint) or death within 90 days of the onset of vasoplegic syndrome		The occurrence of a renal complication (as defined in the primary endpoint) or death within 90 days of the onset of vasoplegic syndrome
Mortality within 90 days of the onset of vasoplegic syndrome		Mortality within 90 days of the onset of vasoplegic syndrome
Occurrence of a cardiac complication as listed below at 7, 30, and 90 days after the onset of vasoplegic syndrome: arrhythmia requiring treatment , postoperative myocardial damage, myocardial infarction defined by an increase in cardiac enzymes plus the appearance of a new Q wave, and/or an abnormality of kinetics on echocardiography, cardiorespiratory arrest		Occurrence of a cardiac complication as listed below at 7, 30, and 90 days after the onset of vasoplegic syndrome: arrhythmia requiring treatment , postoperative myocardial damage, myocardial infarction defined by an increase in cardiac enzymes plus the appearance of a new Q wave, and/or an abnormality of kinetics on echocardiography, cardiorespiratory arrest
The occurrence of a digestive complication as listed below at 7, 30 and 90 days after the onset of the vasoplegic syndrome: mesenteric ischemia, ischemic colitis diagnosed by an imaging examination (CT scan, endoscopy) or the need for a reoperation for digestive complication in the aftermath of the cardiac surgery		The occurrence of a digestive complication as listed below at 7, 30 and 90 days after the onset of the vasoplegic syndrome: mesenteric ischemia, ischemic colitis diagnosed by an imaging examination (CT scan, endoscopy) or the need for a reoperation for digestive complication in the aftermath of the cardiac surgery
The occurrence of a cerebral complication as listed below within 7 days of the onset of the vasoplegic syndrome: stroke, delirium (identified by the CAM-ICU test)		The occurrence of a cerebral complication as listed below within 7 days of the onset of the vasoplegic syndrome: stroke, delirium (identified by the CAM-ICU test)
The number of patients requiring rescue norepinephrine after the onset of vasoplegic syndrome in the OR and postoperatively		The number of patients requiring rescue norepinephrine after the onset of vasoplegic syndrome in the OR and postoperatively
The total dose (mg) of norepinephrine for patients requiring rescue norepinephrine after the onset of vasoplegic syndrome in the OR and postoperatively		The total dose (mg) of norepinephrine for patients requiring rescue norepinephrine after the onset of vasoplegic syndrome in the OR and postoperatively
The Vasoactive Inotropic Score at D0, D1, D2, D7 of the onset of the vasoplegic syndrome (VIS = dopamine dose (mcg kg-1 min-1) + dobutamine dose (mcg kg-1 min-1) + 100 x adrenaline dose (mcg kg-1 min- 1) + 10 x dose of milrinone (mcg kg-1 min-1) + 10,000 x dose of vasopressin (units/kg/min) + 100 x dose of norepinephrine (mcg kg-1 min-1) + 10 x dose of phenylephrine (mcg kg-1 min-1)		The Vasoactive Inotropic Score at D0, D1, D2, D7 of the onset of the vasoplegic syndrome (VIS = dopamine dose (mcg kg-1 min-1) + dobutamine dose (mcg kg-1 min-1) + 100 x adrenaline dose (mcg kg-1 min- 1) + 10 x dose of milrinone (mcg kg-1 min-1) + 10,000 x dose of vasopressin (units/kg/min) + 100 x dose of norepinephrine (mcg kg-1 min-1) + 10 x dose of phenylephrine (mcg kg-1 min-1)
The length of stay in the ICU and hospital (number of days) at D90 of the onset of the vasoplegic syndrome		The length of stay in the ICU and hospital (number of days) at D90 of the onset of the vasoplegic syndrome
The difference in mean costs of ICU and hospital stays at D90 of vasoplegic syndrome onset		The difference in mean costs of ICU and hospital stays at D90 of vasoplegic syndrome onset
The incremental cost-effectiveness ratio at D90 of onset of vasoplegic syndrome, expressed as the cost per additional complication avoided by the vasopressin strategy compared with the noradrenaline strategy		The incremental cost-effectiveness ratio at D90 of onset of vasoplegic syndrome, expressed as the cost per additional complication avoided by the vasopressin strategy compared with the noradrenaline strategy
The incremental cost-effectiveness ratio at D90 of the onset of vasoplegic syndrome, expressed as the cost per additional year of life gained with the vasopressin strategy compared with the noradrenaline strategy		The incremental cost-effectiveness ratio at D90 of the onset of vasoplegic syndrome, expressed as the cost per additional year of life gained with the vasopressin strategy compared with the noradrenaline strategy
Incremental cost-effectiveness ratio at D90 of the onset of vasoplegic syndrome, expressed in terms of cost per additional healthy life-year gained (cost/QALY) with the vasopressin strategy compared with the noradrenaline strategy		Incremental cost-effectiveness ratio at D90 of the onset of vasoplegic syndrome, expressed in terms of cost per additional healthy life-year gained (cost/QALY) with the vasopressin strategy compared with the noradrenaline strategy
The occurrence of hyponatremia (Na+ <130 mmol l-1), hypoperfusion of the extremities (cyanosis/necrosis of the extremities) at D7		The occurrence of hyponatremia (Na+ <130 mmol l-1), hypoperfusion of the extremities (cyanosis/necrosis of the extremities) at D7

Trial Locations

Locations (6): Centre Hospitalier Universitaire De Dijon
🇫🇷
Dijon, France
CHUR Of Besançon
🇫🇷
Besancon Cedex, France
Centre Hospitalier Universitaire Amiens Picardie
🇫🇷
Amiens, France
Centre Hospitalier Regional Universitaire De Nancy
🇫🇷
Vandoeuvre Les Nancy, France
Centre Hospitalier Universitaire De Montpellier
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Montpellier Cedex 5, France
Clinique De La Sauvegarde
🇫🇷
Lyon, France
Centre Hospitalier Universitaire De Dijon
🇫🇷Dijon, France
Pierre-Grégoire GUINOT
Site contact
0380293031
pierregregoire.guinot@chu-dijon.fr