Blood Pressure Management for Low Blood Pressure

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.

The trial information does not specify whether participants need to stop taking their current medications.

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 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.

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