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Perioperative Individualized Optimization of Mean Arterial Pressure in Cardiac Surgery

NCT05403697 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2025-07-25

No results posted yet for this study

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

Interventions

PROCEDURE

Individualized MAP

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.

Sponsors & Collaborators

  • University Hospital, Caen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-12
Primary Completion
2024-05-28
Completion
2025-07-17

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05403697 on ClinicalTrials.gov