Brain Autoregulation Research Study

NCT ID: NCT07221721

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2028-12-31

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.

Detailed Description

Congenital heart disease (CHD) is the most common birth defect.1 Surgery to treat CHD is complicated by white matter injury (WMI) on brain magnetic resonance imaging (MRI) and neurodevelopmental (ND) deficits in 50% to 75% of neonates after CHD surgery.2-6 Cerebral hypoperfusion is a major mechanism of brain injury during both cardiopulmonary bypass (CPB) and the perioperative period in the intensive care unit (ICU).7-10 Investigators lack diagnostic and therapeutic means to reduce cerebral hypoperfusion-associated white matter injury (WMI) and improve long-term ND outcomes.11 Our long-term goal is to use real-time measurement of the cerebral lower limit of autoregulation (LLA) to manage arterial blood pressure, reduce cerebral hypoperfusion-associated brain injury, and improve long-term ND outcomes in children at risk for brain hypoperfusion. In a prospective, single blind, randomized clinical trial (RCT) in adults undergoing cardiac surgery, investigators previously showed that targeted LLA arterial blood pressure management to maintain mean arterial pressure (MAP) above the LLA decreased the incidence of postoperative delirium by 45%.12 Our preliminary data indicate that neonates are exposed to significantly more cerebral hypotension than adult patients undergoing CPB. Our central hypothesis is that a strategy of targeting mean arterial pressure (MAP) to a level above an individual's LLA will reduce the risk for WMI and neurodevelopmental impairment in neonates undergoing congenital heart surgery. Our team has validated methodology to delineate the LLA and demonstrated the important role of cerebral autoregulation monitoring on short-term outcomes in CHD subjects who have undergone CPB.13 We can rigorously measure cerebral autoregulation in real time and the amount of cerebral hypotension (duration and magnitude) through the integration of near infrared spectroscopy (NIRS) and the arterial blood pressure.14,15 The efficacy of an LLA targeted MAP strategy to minimize WMI and improve ND outcomes can only be demonstrated by a prospective, single-blind, multi-center randomized RCT. To obtain funding for this large multi-center RCT will require the demonstration of feasibility and safety, as well as, an estimation of the sample size needed to show efficacy.

Conditions

Hypotension During Surgery; Hypotension Postprocedural

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Surgery with Active MAP Management

Intervention Type: 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.

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.

Group Type: SHAM_COMPARATOR

Surgery without Active MAP Management

Intervention Type: 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.

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 30 Days
• Maximum Eligible Age: 30 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bradley Marino

OTHER

Sponsor Role: lead

Responsible Party

Bradley Marino

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Bradley Marino, MD, MPP, MSSCE, MBA

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

The Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Central Contacts

Monica Young

Role: CONTACT

brutonm@ccf.org

216-442-4401

Facility Contacts

Monica Young

Role: primary

brutonm@ccf.org

2164424401

Other Identifiers

IRB 22-1348

Identifier Type: -

Identifier Source: org_study_id