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

March 11, 2022 updated by: Kenneth Liao, Baylor College of Medicine

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

69

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult subjects implanted with continuous-flow left ventricular assist device

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From initiation of cerebral autoregulation monitoring in operation room until termination of the invasive arterial blood pressure monitoring in ICU (up to 48 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From initiation of cerebral autoregulation monitoring in operation room until termination of the invasive arterial blood pressure monitoring in ICU (up to 48 hours)
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.
From implantation of continuous-flow LVAD until discharge of hospital (up to 4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Collaborators

International Society for Heart and Lung Transplantation

Investigators

  • Principal Investigator: Masahiro Ono, MD, Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2015

Primary Completion (ACTUAL)

March 7, 2018

Study Completion (ACTUAL)

March 7, 2018

Study Registration Dates

First Submitted

February 22, 2017

First Submitted That Met QC Criteria

March 22, 2017

First Posted (ACTUAL)

March 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 25, 2022

Last Update Submitted That Met QC Criteria

March 11, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-34866

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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