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Clinical Trial NCT07221721 for Hypotension During Surgery, Hypotension Postprocedural is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Brain Autoregulation Research Study 130 Randomized

Not yet recruiting
Clinical Trial NCT07221721 is an interventional study for Hypotension During Surgery, Hypotension Postprocedural and is currently not yet recruiting. Enrollment is planned to begin on 1 November 2025 and continue until the study accrues 130 participants. Led by Bradley Marino, this study is expected to complete by 1 December 2028. The latest data from ClinicalTrials.gov was last updated on 30 October 2025.
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)....Show More
Official Title

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

Conditions
Hypotension During SurgeryHypotension Postprocedural
Other Study IDs
  • IRB 22-1348
NCT ID Number
NCT07221721
Start Date (Actual)
2025-11
Last Update Posted
2025-10-30
Completion Date (Estimated)
2028-12
Enrollment (Estimated)
130
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
hypotension
neonates
cardiothoracic surgery with cardiopulmonary bypass
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalIntervention (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.
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.
Sham ComparatorControl 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.
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Aim 2: Lower Limit Autoregulation Monitoring (LLA)
To determine LLA targeted MAP vs standard MAP management in real time will not increase perioperative mortality and morbidity in neonates undergoing cardiac surgery with CPB
First 30 days post-surgery in the ICU
Participation Assistant
Eligibility Criteria

Eligible Ages
Child
Minimum Age
30 Days
Eligible Sexes
All
  • All neonates (<30 days of age)
  • Undergoing cardiothoracic surgery with cardiopulmonary bypass

  • 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)
Bradley Marino logoBradley Marino
Study Responsible Party
Bradley Marino, Sponsor-Investigator, Principal Investigator, The Cleveland Clinic
Study Central Contact
Contact: Monica Young, 216-442-4401, [email protected]
1 Study Locations in 1 Countries

Ohio

The Cleveland Clinic, Cleveland, Ohio, 44195, United States
Monica Young, Contact, 2164424401, [email protected]
Bradley Marino, MD, MPP, MSSCE, MBA, Principal Investigator