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NCT Number: NCT03093012

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

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.

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Key information

Conditions

Heart-assist Devices Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Baylor College of Medicine

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients greater than or equal to 18 years old undergoing continuous-flow left ventricular assist device implantation for the clinical indications of bridge to transplant or destination therapy.

Exclusion criteria

  • Patients < 18 years of age will be ineligible for this study.

Treatment and study plan

Primary outcomes

  1. Individual optimal blood pressure change between before and after continuous-flow LVAD implantation determined by cerebral autoregulation monitoring with NIRS

    Time frame: From initiation of cerebral autoregulation monitoring in operation room until termination of the invasive arterial blood pressure monitoring in ICU (up to 48 hours)

    Using cerebral autoregulation monitoring method, the optimal blood pressure for maintaining cerebral blood flow (CBF) can be determined individually. The individual optimal blood pressure to maintain CBF autoregulation will be determined and assessing change between before and after implantation of continuous-flow LVAD.

Secondary outcomes

  1. Extent of impairment of cerebral autoregulation in perioperative periods

    Time frame: From initiation of cerebral autoregulation monitoring in operation room until termination of the invasive arterial blood pressure monitoring in ICU (up to 48 hours)

    Using cerebral autoregulation monitoring method, the extent of impairment of cerebral autoregulation can be determined (AUCMAP: area under the curve of excursion of mean arterial pressure), which is calculated with magnitude (mmHg) and duration (hour) of mean arterial pressure (MAP) excursions below the individual optimal blood pressure to maintain cerebral autoregulation.

  2. Postoperative adverse events and operative mortality after continuous-flow LVAD implantation.

    Time frame: From implantation of continuous-flow LVAD until discharge of hospital (up to 4 weeks)

    Postoperative adverse events including followings: 1) stroke; persistent neurological deficit >24 hours, 2) renal failure; new requirement for dialysis postoperatively or increase in creatinine to >2 mg/dL and 2 times greater than baseline, acute kidney injury; RIFLE criteria, 3) respiratory failure; mechanical lung ventilation >72 hours or requirement for tracheotomy, 4) right ventricular failure; requirement for right ventricular assist device, 5) operative mortality; all deaths that occur during the hospitalization in which the operation is performed, even if after 30 days, and deaths that occur after discharge from the hospital but within 30 days of the procedure, unless the cause of death was clearly unrelated to the operation.

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • International Society for Heart and Lung Transplantation

Registry information

Official study title

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

Acronym: NIRS

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 28, 2017
Registry last updated
Mar 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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