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WITHDRAWN
NCT07221721
NA

Brain Autoregulation Research Study

Sponsor: Jennie E Minnich

View on ClinicalTrials.gov

Summary

Randomized, multi-site, study assessing the feasibility of lower limit of autoregulation targeted mean arterial pressure (MAP) vs. standard MAP management in neonates undergoing cardiac surgery with cardiopulmonary bypass. After eligibility screening and consent, subjects will be randomized to either the intervention (study) or control group.

Official title: A Pilot Study to Assess the Feasibility and Safety of Targeting Mean Arterial Pressure to Reduce Intra-operative Hypotension

Key Details

Gender

All

Age Range

30 Days - 30 Days

Study Type

INTERVENTIONAL

Enrollment

0

Start Date

2026-06

Completion Date

2028-12

Last Updated

2026-07-15

Healthy Volunteers

No

Interventions

DEVICE

Surgery with Active MAP Management

Neonates undergoing cardiothoracic surgery (CT) utilizing cardiopulmonary bypass (CPB) who will have active management of their mean arterial pressure (MAP) to keep the MAP above the LLA as measured by a novel autoregulation monitoring modality.

OTHER

Surgery without Active MAP Management

Neonates undergoing cardiothoracic surgery (CT) utilizing cardiopulmonary bypass (CPB) who will have management of their MAP by institutional practice without guidance from an autoregulation monitoring modality.

Locations (1)

The Cleveland Clinic

Cleveland, Ohio, United States