Brain Autoregulation Research Study

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Bradley Marino
Study ID
NCT07221721
Status
Not Yet Recruiting

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Conditions

  • Hypotension During Surgery
  • Hypotension Postprocedural

Eligibility Criteria

Sex
ALL
Age
30 Days - 30 Days
Healthy Volunteers
Not accepted

Interventions

  • Surgery with Active MAP Management — DEVICE
    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 — OTHER
    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.

Study Details

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.

Key Dates

Start date
Nov 30, 2025
Status verified
Jun 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention (Study) Group
    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.
  • Sham Comparator: Control Group
    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.

Primary Outcome Measure

Aim 1: Hypotension Exposure [ Time Frame: From beginning of surgery until 72 hours post-surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Cleveland ClinicClevelandOhio44195
Monica Young
[email protected]
2164424401
Bradley Marino, MD, MPP, MSSCE, MBA (PRINCIPAL_INVESTIGATOR)

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By research site
The Cleveland Clinic· Cleveland, OH

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