Optimizing blood pressure during cardiac surgery
Perioperative Individualized Optimization of Mean Arterial Pressure in Cardiac Surgery
This study tests if adjusting blood pressure specifically for each patient during heart surgery can help prevent brain and kidney problems afterwards.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Caen Academic / other |
| Locations | 1 site (Caen) |
| Trial ID | NCT05403697 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of individualized mean arterial pressure (MAP) optimization on reducing neurological and renal complications in patients undergoing cardiac surgery. Conducted across 21 cardiac surgical centers in France, the study randomly assigns patients to receive either individualized MAP management or standard care during the perioperative and postoperative periods. The goal is to maintain MAP levels tailored to each patient's needs, potentially improving outcomes after surgery.
Who should consider this trial
Good fit: Ideal candidates are French-speaking adults over 18 scheduled for elective cardiac surgery involving cardiopulmonary bypass.
Not a fit: Patients with severe renal impairment, neurological disorders, or those undergoing emergency or non-eligible surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of acute renal failure and cognitive dysfunction in cardiac surgery patients.
How similar studies have performed: While the concept of individualized MAP optimization is promising, this specific approach has not been extensively tested in prior studies, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Caen
- Chu Caen — Caen, France (Recruiting)
Study contacts
- Study coordinator: Richard DESCAMPS, M.D.
- Email: descamps-r@chu-caen.fr
- Phone: 0231063334
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.