Perioperative Individualized Optimization of Mean Arterial Pressure in Cardiac Surgery

NCT05403697 | Terminated DMC

• 1 other identifier: 2021-A00340-41
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Mean Arterial Pressure

Keywords

Mean arterial pressure; Cardiac surgery; Hemodynamic optimization

Outcome Measures

Primary Outcomes (1)

• Complications on Day 7

  composite endpoint of mortality, neurological and/or renal complications following surgery

  On day 7

Secondary Outcomes (10)

• Mortality at day 7

  On day 7

• Mortality at day 90

  On day 90 +/- 10 days

• Neurological complications at day 7

  On day 7

• Neurological complications at day 90

  On day 90 +/- 10 days

• Renal complications at day 7

  On day 7

Study Arms (2)

Individualized MAP group

EXPERIMENTAL

Individualized MAP strategy aimed at achieving a mean arterial pressure within 10% of the reference value (ie, patient's resting MAP measured during the preoperative anesthesiology consultation) during the operating room period and the 24h following surgery in the ICU.

Procedure: Individualized MAP

Control group

NO INTERVENTION

Standard management strategy of treating MAP ≥ 65 mmHg, during the operating room period and the 24h following surgery in the ICU. No intervention to actively decrease MAP.

Interventions

Individualized MAP PROCEDURE

Hemodynamic optimization beginning after general anesthesia induction, and ending at the 24th hour postoperatively, which consists in obtaining a mean arterial pressure (MAP) which is at least 90% of the usual MAP of the patient.

Individualized MAP group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CHU CAEN

Caen, France

Location

Related Publications (1)

• Descamps R, Amour J, Besnier E, Bougle A, Charbonneau H, Charvin M, Cholley B, Desebbe O, Fellahi JL, Frasca D, Labaste F, Lena D, Mahjoub Y, Mertes PM, Molliex S, Moury PH, Moussa MD, Oilleau JF, Ouattara A, Provenchere S, Rozec B, Parienti JJ, Fischer MO; OPTIPAM investigators. Perioperative individualized hemodynamic optimization according to baseline mean arterial pressure in cardiac surgery patients: Rationale and design of the OPTIPAM randomized trial. Am Heart J. 2023 Jul;261:10-20. doi: 10.1016/j.ahj.2023.03.005. Epub 2023 Mar 18.

  PMID: 36934980 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial, open Phase 3 without experimental product, but experimental strategy

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 3, 2022
• Study Start: January 12, 2023
• Primary Completion: May 28, 2024
• Study Completion: July 17, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)