Brain Autoregulation Research Study

NCT07221721 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: IRB 22-1348
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypotension During Surgery; Hypotension Postprocedural

Keywords

hypotension; neonates; cardiothoracic surgery with cardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

• Aim 1: Hypotension Exposure

  Primary outcome is to reduce hypotension exposure, defined as the product of duration and magnitude of arterial blood pressure below LLA measured in the operating room and for the first 72 hours in the ICU.

  From beginning of surgery until 72 hours post-surgery

Secondary Outcomes (1)

• Aim 2: Lower Limit Autoregulation Monitoring (LLA)

  First 30 days post-surgery in the ICU

Other Outcomes (1)

• Aim 3: Mean Arterial Pressure Management

  Seizure assessment by EEG first 48 hours post-op, White matter injury assessment by Brain MRI 7-21 days post-op, neurodevelopmental outcome (neurobehavioral assessment at 30 days or at discharge by the NBO, Bayley-4 at 6 and 12 months).

Study Arms (2)

Intervention (Study) Group

EXPERIMENTAL

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.

Device: Surgery with Active MAP Management

Control Group

SHAM COMPARATOR

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.

Other: Surgery without Active MAP Management

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.

Intervention (Study) Group

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.

Control Group

Eligibility Criteria

• Age: 30 Days - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All neonates (\<30 days of age)
• Undergoing cardiothoracic surgery with cardiopulmonary bypass

You may not qualify if:

• Less than full term (\<37 weeks gestation)
• Weight \< 2.50kg
• Genetic abnormality or syndrome except heterotaxy syndrome
• Major non-cardiac anomalies (e.g. congenital diaphragmatic hernia, - omphalocele, holoprosencephaly, anencephaly)

Sponsors & Collaborators

• Bradley Marino: lead

Study Sites (1)

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Hypotension

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bradley Marino, MD, MPP, MSSCE, MBA

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monica Young

CONTACT

216-442-4401; brutonm@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2025
• First Posted: October 28, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 30, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)