NCT03093012

Individual Blood Pressure Optimization Based on Cerebral Autoregulation After Implantation of Continuous-flow LVAD

Individual Blood Pressure Optimization Based on Cerebral Blood Flow Autoregulation After Implantation of Continuous-flow Left Ventricular Assist Device

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 69 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will collect retrospective and prospective clinical data regarding the Principal Investigator's patient population to allow for data analysis seeking basic trends and to prepare academic reports, including journal manuscripts and presentations for scientific organizations.

Detailed description

Preoperative data will be collected as the baseline information through chart review and patient interview before the surgery as follows: patient demographics, co-morbidities, medication, preoperative laboratory results, and preoperative vital signs. Intraoperative data will be collected by chart review or monitor review as follows: type of implant device, concomitant procedures, length of surgery, duration of cardiopulmonary bypass and aortic cross clamp, blood products administered hemodynamic variables, and NIRS signals. Postoperative data will be collected by chart review or monitor review as follows: medications, blood products administered, postoperative laboratory results, adverse events and operative mortality\*, length of mechanical ventilation, length of inotrope administered, hemodynamic variables, length of intensive care unit and hospital stay, mortality, and NIRS signals. Participants will receive routine standard institutional perioperative care that included invasive radial artery blood pressure monitoring. Participants will be connected to the NIRS monitor using sensor probes placed on the right and left sides of the forehead per routine clinical application. NIRS signal monitoring will be initiated before induction of general anesthesia in the operation room for collecting baseline data, and continued during LVAD implantation procedure. After implantation of LVAD, continuous NIRS monitoring will be carried out in the ICU until termination of the invasive arterial blood pressure monitoring. For all participants enrolled in this study, all medical treatment which is provided will not deviate from the standard of clinical care, including surgery and other procedures as well as blood sample collection. The data will be reviewed routinely to seek trends. When needed to examine specific clinical issues, such as risk factors for a given complication, additional clinical data will be retrieved from the medical records. All data sets analyzed and used for presentations or publication will be anonymized to protect patient confidentiality. This study will be conducted indefinitely.

Conditions

• Heart-Assist Devices
• Heart Failure

Timeline

• Start date: 2015-08-01
• Primary completion: 2018-03-07
• Completion: 2018-03-07
• First posted: 2017-03-28
• Last updated: 2022-03-25

Locations

1 site across 1 country: United States