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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental |
| |
| Control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vasopressin | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of a renal complication or death | From the onset of the vasoplegic syndrome until 7 days after |
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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:
Patient with at least 3 risk factors for acute kidney failure including:
Exclusion Criteria:
Secondary exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Dijon Bourgogne | Dijon | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38492626 | Derived | 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. |
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| Norepinephrine | Drug | 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 data | Other | At D1, D2, D7, D30 or D60 and D90 |
|
| Quality of Life Questionnaire EQ-5D | Other | At the anesthesia consultation, discharge from intensive care, D7, D30 and D90 |
|
| ID | Term |
|---|---|
| D056987 | Vasoplegia |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014667 | Vasopressins |
| D009638 | Norepinephrine |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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