Impact of Cardiopulmonary Bypass Flow on Cerebral Autoregulation

NCT05681741 | Completed

• 1 other identifier: Ramsay Sante Sauvegarde Clinic
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Cerebral autoregulation is defined by the capacity of the brain to maintain a constant cerebral blood flow (CBF) despite variations of arterial pressure. However, when the arterial pressure is below a critical threshold, cerebral blood decreases. This critical threshold is called the lower limit of cerebral autoregulation (LLA). Cardiopulmonary bypass is a unique environment wherein systemic blood flow is totally controlled by the cardiopulmonary bypass pump. High pump flows combined with low arterial pressures has been shown to not compromise neurologic postoperative outcomes. Our hypothesis is that that LLA may depend on the cardiopulmonary bypass flow, ie the LLA may decrease when the cardiopulmonary bypass flow increases, explaining why low arterial pressure may be well tolerated.

Conditions

Cerebral Autoregulation; Cardiopulmonary Bypass; Mean Arterial Pressure

Keywords

FlowMapca

Outcome Measures

Primary Outcomes (1)

• measurement of MAP LLA (mmHg)

  Determination of MAP LLA according to the calculation of the mean velocity index

  15 to 25 min during the procedure

Study Arms (2)

current pump flow (between 2 and 2.4 l/min/m²)

SHAM COMPARATOR

the pump flow will be constant during this randomized phase

Procedure: current versus high pump flow

high pump flow (between 2.6 and 3 l/min/m²)

ACTIVE COMPARATOR

the pump flow will be constant during this randomized phase

Procedure: current versus high pump flow

Interventions

current versus high pump flow PROCEDURE

during each phase of randomized pump flow, arterial pressure will be increased from 40 to 90 mmHg with vasodilators and/or vasoconstrictors

current pump flow (between 2 and 2.4 l/min/m²); high pump flow (between 2.6 and 3 l/min/m²)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient, male or female, over the age of 18
• Patient scheduled to undergo valvular heart surgery with planned CPB
• Patient with a Euroscore below 7%
• Patient affiliated or entitled to a social security scheme
• Patient having received informed information about the study and having signed a free and informed consent to participate in the study

You may not qualify if:

• Patient with untreated or uncontrolled severe hypertension despite treatment
• Patient with chronic renal failure, with glomerular filtration \< 30 mL/min/1.73m² or requiring a kidney transplant
• Patient with left ventricular ejection fraction \< 40%
• Patient with a history of ischemic stroke
• Patient having or about to benefit from renal vascular surgery
• Patient with preoperative sepsis
• Patient who required a norepinephrine infusion within 24 hours before surgery
• Patient presenting with an inaccessible temporal Doppler window
• Patient candidate for emergency surgery
• Pregnant, parturient or breastfeeding woman
• Patient with preoperative uni or bilateral carotid stenosis \> 50%
• Protected patient: adult under guardianship, curators or other legal protection, deprived of liberty by judicial or administrative decision

Sponsors & Collaborators

• Clinique de la Sauvegarde: lead
• GCS Ramsay Santé pour l'Enseignement et la Recherche: collaborator

Study Sites (1)

Clinique de la Sauvegarde

Lyon, 69009, France

Location

Study Officials

• Olivier Desebbe, MD

  Clinique de la Sauvegarde

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: parallel affectation

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: January 12, 2023
• Study Start: January 8, 2023
• Primary Completion: July 3, 2023
• Study Completion: September 12, 2023
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)