Clinical trial NCT03093012: Individual Blood Pressure Optimization Based on Cerebral Autoregulation After Implantation of Continuous-flow LVAD
Official title: Individual Blood Pressure Optimization Based on Cerebral Blood Flow Autoregulation After Implantation of Continuous-flow Left Ventricular Assist Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart-Assist Devices
Heart Failure
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: International Society for Heart and Lung Transplantation
First posted: 2017-03-28
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult subjects implanted with continuous-flow left ventricular assist device

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Individual optimal blood pressure change between before and after continuous-flow LVAD implantation determined by cerebral autoregulation monitoring with NIRS
timeFrame: 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 outcomes:
measure: Extent of impairment of cerebral autoregulation in perioperative periods
timeFrame: From initiation of cerebral autoregulation monitoring in operation room until termination of the invasive arterial blood pressure monitoring in ICU (up to 48 hours)
measure: Postoperative adverse events and operative mortality after continuous-flow LVAD implantation.
timeFrame: From implantation of continuous-flow LVAD until discharge of hospital (up to 4 weeks)
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Masahiro Ono, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brady K, Joshi B, Zweifel C, Smielewski P, Czosnyka M, Easley RB, Hogue CW Jr. Real-time continuous monitoring of cerebral blood flow autoregulation using near-infrared spectroscopy in patients undergoing cardiopulmonary bypass. Stroke. 2010 Sep;41(9):1951-6. doi: 10.1161/STROKEAHA.109.575159. Epub 2010 Jul 22.
citation: Brady KM, Lee JK, Kibler KK, Smielewski P, Czosnyka M, Easley RB, Koehler RC, Shaffner DH. Continuous time-domain analysis of cerebrovascular autoregulation using near-infrared spectroscopy. Stroke. 2007 Oct;38(10):2818-25. doi: 10.1161/STROKEAHA.107.485706. Epub 2007 Aug 30.
citation: Ono M, Joshi B, Brady K, Easley RB, Kibler K, Conte J, Shah A, Russell SD, Hogue CW. Cerebral blood flow autoregulation is preserved after continuous-flow left ventricular assist device implantation. J Cardiothorac Vasc Anesth. 2012 Dec;26(6):1022-8. doi: 10.1053/j.jvca.2012.07.014.
citation: Ono M, Brady K, Easley RB, Brown C, Kraut M, Gottesman RF, Hogue CW Jr. Duration and magnitude of blood pressure below cerebral autoregulation threshold during cardiopulmonary bypass is associated with major morbidity and operative mortality. J Thorac Cardiovasc Surg. 2014 Jan;147(1):483-9. doi: 10.1016/j.jtcvs.2013.07.069. Epub 2013 Sep 26.
citation: Ono M, Arnaoutakis GJ, Fine DM, Brady K, Easley RB, Zheng Y, Brown C, Katz NM, Grams ME, Hogue CW. Blood pressure excursions below the cerebral autoregulation threshold during cardiac surgery are associated with acute kidney injury. Crit Care Med. 2013 Feb;41(2):464-71. doi: 10.1097/CCM.0b013e31826ab3a1.
citation: Aries MJ, Czosnyka M, Budohoski KP, Steiner LA, Lavinio A, Kolias AG, Hutchinson PJ, Brady KM, Menon DK, Pickard JD, Smielewski P. Continuous determination of optimal cerebral perfusion pressure in traumatic brain injury. Crit Care Med. 2012 Aug;40(8):2456-63. doi: 10.1097/CCM.0b013e3182514eb6.
citation: Lee JK, Kibler KK, Benni PB, Easley RB, Czosnyka M, Smielewski P, Koehler RC, Shaffner DH, Brady KM. Cerebrovascular reactivity measured by near-infrared spectroscopy. Stroke. 2009 May;40(5):1820-6. doi: 10.1161/STROKEAHA.108.536094. Epub 2009 Mar 12.