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

NCT03093012 | Completed

• 1 other identifier: H-34866
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart-Assist Devices; Heart Failure

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (2)

• Extent of impairment of cerebral autoregulation in perioperative periods

  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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult subjects implanted with continuous-flow left ventricular assist device

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• International Society for Heart and Lung Transplantation: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (7)

• 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.

  PMID: 20651274 BACKGROUND

• 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.

  PMID: 17761921 BACKGROUND

• 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.

  PMID: 23122299 BACKGROUND

• 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.

  PMID: 24075467 BACKGROUND

• 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.

  PMID: 23263580 BACKGROUND

• 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.

  PMID: 22622398 BACKGROUND

• 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.

  PMID: 19286593 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Masahiro Ono, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 28, 2017
• Study Start: August 1, 2015
• Primary Completion: March 7, 2018
• Study Completion: March 7, 2018
• Last Updated: March 25, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)