Brain Autoregulation Research Study

ConditionsHypotension During Surgery Hypotension Postprocedural

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age30-30

SponsorBradley Marino

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All neonates (<30 days of age)

Undergoing cardiothoracic surgery with cardiopulmonary bypass

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

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 intervention
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.

Treatment groups

130 Participants

are divided into 2 treatment groups

Group A: Intervention (Study) GroupExperimental treatment 1 intervention

Group B: Control GroupSham comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

From beginning of surgery until 72 hours post-surgery

Secondary outcomes

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

Time frame

First 30 days post-surgery in the ICU

Other outcomes

Aim 3: Mean Arterial Pressure Management

Compare LLA targeted MAP vs standard of care MAP management in reducing white matter injury and seizure occurrence and improve neurodevelopment outcomes.

Time frame

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).

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bradley Marino

Lead sponsor

The Cleveland Clinic

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: