Blood Pressure Management for Low Blood Pressure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to find better ways to manage blood pressure during heart surgery for newborns. It will test two approaches: one uses a special monitoring tool to maintain steady blood pressure (Surgery with Active MAP Management), and the other follows standard care without this tool (Surgery without Active MAP Management). The goal is to determine if the new method can improve outcomes for babies undergoing heart surgery. Newborns less than 30 days old who need heart surgery with a heart-lung machine may be eligible to join. As an unphased trial, this study offers a unique opportunity for participants to contribute to pioneering research that could enhance surgical outcomes for newborns.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether participants need to stop taking their current medications.
What prior data suggests that this protocol is safe for neonates undergoing cardiac surgery?
Research has shown that carefully controlling blood pressure during heart surgery can be done safely. Studies suggest that maintaining higher blood pressure levels during surgery might aid in better recovery. However, evidence also indicates that this approach could increase the risk of certain issues, such as atrial fibrillation, an irregular heartbeat.
Researchers are testing this method of managing blood pressure to determine if it can enhance recovery after surgery. While it appears promising, some risks remain, and these are under close examination. Prospective trial participants can use this information to understand the potential benefits and risks.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a new method of managing low blood pressure in neonates undergoing cardiothoracic surgery. Unlike the current standard of care, which follows institutional practice without specific guidance, this trial uses a novel autoregulation monitoring modality to actively manage mean arterial pressure (MAP). This approach could potentially optimize blood pressure control during surgery, offering a more precise and responsive method than existing options, which could lead to better outcomes for these vulnerable patients.
What evidence suggests that this trial's treatments could be effective for managing low blood pressure in neonates undergoing cardiac surgery?
Research shows that controlling blood pressure during surgery is crucial. Studies have found that excessively low blood pressure during surgery can lead to worse health outcomes afterward. Maintaining stable blood pressure is especially important during complex surgeries, such as those involving a machine that temporarily takes over the heart and lungs. In this trial, one group of neonates undergoing cardiothoracic surgery will have active management of their mean arterial pressure (MAP) using a novel autoregulation monitoring modality to keep the MAP above the lower limit of autoregulation (LLA). Evidence suggests that this system can help maintain safer blood pressure levels, potentially improving recovery and reducing complications for patients.678910
Who Is on the Research Team?
Bradley Marino, MD, MPP, MSSCE, MBA
Principal Investigator
The Cleveland Clinic
Are You a Good Fit for This Trial?
This trial is for newborns under 30 days old needing heart surgery with cardiopulmonary bypass. They must weigh at least 2.5kg and be born after a full-term pregnancy without major non-cardiac anomalies or genetic abnormalities, except heterotaxy syndrome.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Neonates undergo cardiothoracic surgery with cardiopulmonary bypass, with MAP management either above LLA or by standard practice
Post-operative Monitoring
Monitoring of hypotension exposure and MAP management in the ICU
Follow-up
Assessment of white matter injury, seizure occurrence, and neurodevelopmental outcomes
Long-term Follow-up
Neurodevelopmental outcome assessments at 6 and 12 months
What Are the Treatments Tested in This Trial?
Interventions
- Surgery with Active MAP Management
- Surgery without Active MAP Management
Trial Overview
The study compares two approaches during neonatal cardiac surgery: one group receives standard blood pressure management (control), while the other has targeted management based on brain blood flow needs (intervention). Participants are randomly assigned to either group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo 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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bradley Marino
Lead Sponsor
Citations
The exploration of perioperative hypotension subtypes
Blood pressure management is an everlasting topic in perioperative medicine. Varying degrees of hypotension are commonly encountered during ...
Intraoperative hypotension and postoperative outcomes
Intraoperative hypotension is associated with adverse postoperative outcomes; however these findings are supported only by observational studies.
Intraoperative hypotension and postoperative outcomes
Intraoperative hypotension is associated with adverse postoperative outcomes; however these findings are supported only by observational studies.
Decision Support for Intraoperative Low Blood Pressure
The purpose of this study is to determine whether a decision support system can improve the adherence to thresholds for low blood pressure by anesthesia ...
The hidden cost of hypotension: redefining hemodynamic ...
Growing evidence suggests that even short episodes of intraoperative hypotension, lasting only a few minutes, can negatively affect clinical outcomes.
Cardiopulmonary bypass management and risk of new-onset ...
Cardiopulmonary bypass (CPB) management may potentially play a role in the development of new-onset atrial fibrillation (AF) after cardiac surgery.
Improvement of outcomes after coronary artery bypass
Higher mean arterial pressures during cardiopulmonary bypass can be achieved in a technically safe manner and effectively improve outcomes after coronary ...
Perioperative Individualized Optimization of Mean Arterial ...
The primary objective is to assess if an individualized MAP strategy (+/- 10% of the resting MAP) conducted in per and postoperative cardiac surgery decrease a ...
THE SAFETY AND EFFICACY OF HIGHER COMPARED ...
The available evidence suggests that higher blood pressure targets during CPB may decrease ICU length-of-stay while increasing the risk of receiving a ...
High-Target Versus Low-Target Blood Pressure ...
It is unclear whether a higher versus a lower blood pressure during cardiopulmonary bypass reduces cerebral infarction in these patients.
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