Hypotension During SurgeryNCT07221721
Brain Autoregulation Research Study
A study testing Surgery with Active MAP Management and Surgery without Active MAP Management in people with Hypotension During Surgery and Hypotension Postprocedural, run by Jennie E Minnich at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 30 days
- Conditions the study is for
- Hypotension During Surgery, Hypotension Postprocedural
- What is being tested?
- Surgery with Active MAP Management and Surgery without Active MAP Management
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All neonates (<30 days of age)
- Undergoing cardiothoracic surgery with cardiopulmonary bypass
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Assess the Feasibility and Safety of Targeting Mean Arterial Pressure to Reduce Intra-operative Hypotension
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.
Read the 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.
- Being tested
- Surgery with Active MAP Management, Surgery without Active MAP Management
- Keywords
- hypotension, neonates, cardiothoracic surgery with cardiopulmonary bypass
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery with Active MAP ManagementDevice
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 ManagementOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Surgery without Active MAP Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From beginning of surgery until 72 hours post-surgery
Secondary outcomes (1)
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
Measured: First 30 days post-surgery in the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2025
- Study startJun 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Why it stopped: PI departure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension During SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennie E Minnich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jennie E Minnich, The Cleveland Clinic
- Investigators
- Bradley Marino, MD, MPP, MSSCE, MBA, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221721
- Sponsor's protocol ID
- IRB 22-1348
- Status last verified
- Jul 2026
- First submitted
- 25 Oct 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Feasibility and Safety of Targeting Mean Arterial Pressure to Reduce Intra-operative Hypotension
- ClinicalTrials.gov ID
- NCT07221721
- Acronym / sponsor ID
- IRB 22-1348
- Keywords
- hypotension, neonates, cardiothoracic surgery with cardiopulmonary bypass
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI departure
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jennie E MinnichUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (Study) Group | Experimental | Device: Surgery with Active MAP ManagementNeonates 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 | Sham comparator | Other: Surgery without Active MAP ManagementNeonates 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. |
Who may qualify
- Ages
- 30 to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- All neonates (<30 days of age)
- Undergoing cardiothoracic surgery with cardiopulmonary bypass
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery with Active MAP ManagementNeonates 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 | Intervention (Study) Group |
| Surgery without Active MAP ManagementNeonates 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 | Control Group |
Primary outcome
Aim 1: Hypotension Exposure
Time frame: From beginning of surgery until 72 hours post-surgery
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.
1 secondary outcome
Aim 2: Lower Limit Autoregulation Monitoring (LLA)
Time frame: First 30 days post-surgery in the ICU
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley Marino, MD, MPP, MSSCE, MBA principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery with Active MAP Management and Surgery without Active MAP Management in people with Hypotension During Surgery and Hypotension Postprocedural, run by Jennie E Minnich at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1: Hypotension Exposure (time frame: From beginning of surgery until 72 hours post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.