TerminatedNot Applicable

Perioperative Individualized Optimization of Mean Arterial Pressure in Cardiac Surgery

Stopped: security matters

France172 participantsStarted 2023-01-12

Plain-language summary

Neurologic and renal complications frequently occur after cardiac surgery. Acute renal failure following cardiac surgery increase the risk of chronic kidney disease, while postoperative neurological complications increased the risk of chronic cognitive dysfunction. Many cardiac surgical patients suffer from systemic hypertension, but the goal in clinical practice is to maintain the mean arterial pressure (MAP) above 65 mmHg. The investigators test the hypothesis that an individualized MAP optimization during the per-operative and the 24 hours postoperative period should decrease the renal and neurological complications following cardiac surgery. The investigators propose a randomized controlled study conducted in 21 French cardiac surgical centers. Patients scheduled for aortic or coronary by-pass without neurological or renal dysfunction could be allocated to either individualized MAP group (individualized (+/- 10% of the resting MAP measured during the preoperative anesthesiology consultation) or control group (MAP ≥ 65mmHg). In each group, the first hemodynamic time follows fluid optimization and goal directed perfusion during cardio-pulmonary by-pass to test only the MAP as objective during the peroperative and first 24 hours following surgery. The vasopressors used will be carefully protocolized using norepinephrine to objectively test the clinical interest of MAP value more than vasopressor type. The primary objective is to assess if an individualized MAP strategy (+/- 10% of the resting MAP) conducted in per and postoperative cardiac surgery decrease a composite endpoint (mortality, neurological and/or renal complications following surgery), in comparison with a control group corresponding to the clinical routine (MAP ≥ 65 mmHg).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \> 18 yr * Patient scheduled for cardiac surgery with cardiopulmonary bypass (aortic valve repair or replacement and/or aortic surgery with normothermia and/or coronary artery bypass) * Patient able to understand and voluntarily sign an informed consent form * Patient able to adhere to the study visit schedule and other protocol requirements * Patient affiliated with an appropriate social security system. * French speaking patient Exclusion Criteria: * Glomerular filtration rate \< 30 ml/min/1.73m2 * Neurologic disorder (motor and/or sensory deficit, cognitive disorder) * Another type of surgery (emergency surgery, mitral or tricuspid repair or replacement, congenital surgery) * Left ventricular ejection fraction \< 30% or acute heart failure in the month before surgery * Pulmonary artery pressure \> 60 mmHg * Endocarditis * Surgery with hypothermia (\< 34°C) * Hepatic cirrhosis (Score Child-Pugh ≥ 7) * Alcohol use disorder (Score AUDIT C ≥ 5) * Refusal to consent or adults with protective measures (curatorship or tutorship or safeguarding justice or juridical protection) * Pregnancy or breast-feeding

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Complications on Day 7

Timeframe: On day 7

Trial details

NCT IDNCT05403697

SponsorUniversity Hospital, Caen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-28

View on ClinicalTrials.gov More Mean Arterial Pressure trials