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Brain Autoregulation Research Study
Sponsor: Bradley Marino
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
130
Start Date
2025-11
Completion Date
2028-12
Last Updated
2025-10-30
Healthy Volunteers
No
Interventions
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.
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