Cerebral Autoregulation Monitoring During Cardiac Surgery

NCT00981474 | Completed Results DMC FDA Device

• 2 other identifiers: 6801R01HL092259
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

Brief Summary

Neurological complications from cardiac surgery are an important source of operative mortality, prolonged hospitalization, health care expenditure, and impaired quality of life. New strategies of care are needed to avoid rising complications for the growing number of aged patients undergoing cardiac surgery. This study will evaluate novel methods for reducing brain injury during surgery from inadequate brain blood flow using techniques that could be widely employed.

Conditions

Thoracic Surgery; Cardiopulmonary Bypass

Keywords

cardiac surgery; brain injury; cerebral autoregulation

Outcome Measures

Primary Outcomes (1)

• Composite Neurological Outcome of Clinical Stroke or New Ischemic Brain Lesion on Diffusion Weighted MRI or Neurocognitive Dysfunction 4 to 6 Weeks After Surgery.

  The composite neurological outcome was composed of clinical stroke, or new ischemic lesions detected on postoperative brain diffusion weighted magnetic resonance imaging(DWI), or cognitive decline from baseline to 4-6 weeks after surgery.

  Up to 6 weeks post-operative

Secondary Outcomes (10)

• Postoperative Delirium

  Postoperative days 1-4

• Multiple Inotropic Drugs>24 Hours After Surgery

  7 days after surgery

• Mechanical Lung Ventilation>24 Hours After Surgery

  Up to 28 days after surgery.

• Insertion of Intra-aortic Balloon Pump

  7 days after surgery

• Postoperative Atrial Fibrillation

  Up to 28 days after surgery.

Study Arms (2)

Control

ACTIVE COMPARATOR

Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management.

Device: Control group

Intervention

EXPERIMENTAL

Blood pressure management based on cerebral autoregulation data.

Drug: blood pressure maintenance based on cerebral blood flow autoregulation measurement

Interventions

Control group DEVICE

Institutional standard of care.

Also known as: Usual (Control Group)

Control

blood pressure maintenance based on cerebral blood flow autoregulation measurement DRUG

Blood pressure lowered or raised

Also known as: Autoregulation

Intervention

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients undergoing primary or re-operative Coronary Artery Bypass Graft (CABG) and/or valvular surgery or ascending aorta surgery that requires Cardio-pulmonary bypass (CPB) who are at high risk for neurologic complications (stroke or encephalopathy) as determined by a Johns Hopkins risk score of \>0.02

You may not qualify if:

• Contraindication to MRI imaging (e.g., permanent pacemaker, cerebral arterial vascular clips)
• Liver function test before surgery more than twice the upper limit of institutional normal
• Pre-existing renal dysfunction defined as an estimated glomerular filtration rate of ≤60 mL/min, or current renal dialysis
• Emergency surgery
• Inability to attend outpatient visits
• Visual impairment or inability to speak and read English. The patient will be excluded from further study if an adequate temporal window for Transcranial Doppler (TCD) monitoring can not be identified before surgery.

Sponsors & Collaborators

• Northwestern University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (32)

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  PMID: 16790619 BACKGROUND

• Gottesman RF, Hillis AE, Grega MA, Borowicz LM Jr, Selnes OA, Baumgartner WA, McKhann GM. Early postoperative cognitive dysfunction and blood pressure during coronary artery bypass graft operation. Arch Neurol. 2007 Aug;64(8):1111-4. doi: 10.1001/archneur.64.8.noc70028. Epub 2007 Jun 11.

  PMID: 17562924 BACKGROUND

• Gottesman RF, Sherman PM, Grega MA, Yousem DM, Borowicz LM Jr, Selnes OA, Baumgartner WA, McKhann GM. Watershed strokes after cardiac surgery: diagnosis, etiology, and outcome. Stroke. 2006 Sep;37(9):2306-11. doi: 10.1161/01.STR.0000236024.68020.3a. Epub 2006 Jul 20.

  PMID: 16857947 BACKGROUND

• Nomura Y, Faegle R, Hori D, Al-Qamari A, Nemeth AJ, Gottesman R, Yenokyan G, Brown C, Hogue CW. Cerebral Small Vessel, But Not Large Vessel Disease, Is Associated With Impaired Cerebral Autoregulation During Cardiopulmonary Bypass: A Retrospective Cohort Study. Anesth Analg. 2018 Dec;127(6):1314-1322. doi: 10.1213/ANE.0000000000003384.

  PMID: 29677060 BACKGROUND

• Czosnyka M, Brady K, Reinhard M, Smielewski P, Steiner LA. Monitoring of cerebrovascular autoregulation: facts, myths, and missing links. Neurocrit Care. 2009;10(3):373-86. doi: 10.1007/s12028-008-9175-7. Epub 2009 Jan 6.

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• 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.

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  PMID: 29771710 BACKGROUND

• Brown CH 4th, Neufeld KJ, Tian J, Probert J, LaFlam A, Max L, Hori D, Nomura Y, Mandal K, Brady K, Hogue CW; Cerebral Autoregulation Study Group; Shah A, Zehr K, Cameron D, Conte J, Bienvenu OJ, Gottesman R, Yamaguchi A, Kraut M. Effect of Targeting Mean Arterial Pressure During Cardiopulmonary Bypass by Monitoring Cerebral Autoregulation on Postsurgical Delirium Among Older Patients: A Nested Randomized Clinical Trial. JAMA Surg. 2019 Sep 1;154(9):819-826. doi: 10.1001/jamasurg.2019.1163.

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  PMID: 2730378 BACKGROUND

• Evered L, Eckenhoff RG; International Perioperative Cognition Nomenclature Working Group. Perioperative cognitive disorders. Response to: Postoperative delirium portends descent to dementia. Br J Anaesth. 2017 Dec 1;119(6):1241. doi: 10.1093/bja/aex404. No abstract available.

  PMID: 29156035 BACKGROUND

• Kellum JA, Lameire N; KDIGO AKI Guideline Work Group. Diagnosis, evaluation, and management of acute kidney injury: a KDIGO summary (Part 1). Crit Care. 2013 Feb 4;17(1):204. doi: 10.1186/cc11454.

  PMID: 23394211 BACKGROUND

• Lameire N, Kellum JA; KDIGO AKI Guideline Work Group. Contrast-induced acute kidney injury and renal support for acute kidney injury: a KDIGO summary (Part 2). Crit Care. 2013 Feb 4;17(1):205. doi: 10.1186/cc11455.

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• Mathew JP, Mackensen GB, Phillips-Bute B, Grocott HP, Glower DD, Laskowitz DT, Blumenthal JA, Newman MF; Neurologic Outcome Research Group (NORG) of the Duke Heart Center. Randomized, double-blinded, placebo controlled study of neuroprotection with lidocaine in cardiac surgery. Stroke. 2009 Mar;40(3):880-7. doi: 10.1161/STROKEAHA.108.531236. Epub 2009 Jan 22.

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• Vedel AG, Holmgaard F, Rasmussen LS, Langkilde A, Paulson OB, Lange T, Thomsen C, Olsen PS, Ravn HB, Nilsson JC. High-Target Versus Low-Target Blood Pressure Management During Cardiopulmonary Bypass to Prevent Cerebral Injury in Cardiac Surgery Patients: A Randomized Controlled Trial. Circulation. 2018 Apr 24;137(17):1770-1780. doi: 10.1161/CIRCULATIONAHA.117.030308. Epub 2018 Jan 16.

  PMID: 29339351 BACKGROUND

• Gold JP, Charlson ME, Williams-Russo P, Szatrowski TP, Peterson JC, Pirraglia PA, Hartman GS, Yao FS, Hollenberg JP, Barbut D, et al. Improvement of outcomes after coronary artery bypass. A randomized trial comparing intraoperative high versus low mean arterial pressure. J Thorac Cardiovasc Surg. 1995 Nov;110(5):1302-11; discussion 1311-4. doi: 10.1016/S0022-5223(95)70053-6.

  PMID: 7475182 BACKGROUND

• Siepe M, Pfeiffer T, Gieringer A, Zemann S, Benk C, Schlensak C, Beyersdorf F. Increased systemic perfusion pressure during cardiopulmonary bypass is associated with less early postoperative cognitive dysfunction and delirium. Eur J Cardiothorac Surg. 2011 Jul;40(1):200-7. doi: 10.1016/j.ejcts.2010.11.024. Epub 2010 Dec 18.

  PMID: 21168339 BACKGROUND

• Joshi B, Ono M, Brown C, Brady K, Easley RB, Yenokyan G, Gottesman RF, Hogue CW. Predicting the limits of cerebral autoregulation during cardiopulmonary bypass. Anesth Analg. 2012 Mar;114(3):503-10. doi: 10.1213/ANE.0b013e31823d292a. Epub 2011 Nov 21.

  PMID: 22104067 BACKGROUND

• Cook DJ, Huston J 3rd, Trenerry MR, Brown RD Jr, Zehr KJ, Sundt TM 3rd. Postcardiac surgical cognitive impairment in the aged using diffusion-weighted magnetic resonance imaging. Ann Thorac Surg. 2007 Apr;83(4):1389-95. doi: 10.1016/j.athoracsur.2006.11.089.

  PMID: 17383345 BACKGROUND

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  PMID: 17761921 BACKGROUND

• Lewis C, Dokucu ME, Brown CH, Balmert L, Srdanovic N, Madhan AS, Samra SS, Csernansky J, Grafman J, Hogue CW. Postoperative but not preoperative depression is associated with cognitive impairment after cardiac surgery: exploratory analysis of data from a randomized trial. BMC Anesthesiol. 2022 May 23;22(1):157. doi: 10.1186/s12871-022-01672-y.

  PMID: 35606688 DERIVED

• Nakano M, Nomura Y, Suffredini G, Bush B, Tian J, Yamaguchi A, Walston J, Hasan R, Mandal K, Schena S, Hogue CW, Brown CH 4th. Functional Outcomes of Frail Patients After Cardiac Surgery: An Observational Study. Anesth Analg. 2020 Jun;130(6):1534-1544. doi: 10.1213/ANE.0000000000004786.

  PMID: 32384343 DERIVED

• Nomura Y, Nakano M, Bush B, Tian J, Yamaguchi A, Walston J, Hasan R, Zehr K, Mandal K, LaFlam A, Neufeld KJ, Kamath V, Hogue CW, Brown CH 4th. Observational Study Examining the Association of Baseline Frailty and Postcardiac Surgery Delirium and Cognitive Change. Anesth Analg. 2019 Aug;129(2):507-514. doi: 10.1213/ANE.0000000000003967.

  PMID: 30540612 DERIVED

• Hori D, Katz NM, Fine DM, Ono M, Barodka VM, Lester LC, Yenokyan G, Hogue CW. Defining oliguria during cardiopulmonary bypass and its relationship with cardiac surgery-associated acute kidney injury. Br J Anaesth. 2016 Dec;117(6):733-740. doi: 10.1093/bja/aew340.

  PMID: 27956671 DERIVED

• Brown CH 4th, Faigle R, Klinker L, Bahouth M, Max L, LaFlam A, Neufeld KJ, Mandal K, Gottesman RF, Hogue CW Jr. The Association of Brain MRI Characteristics and Postoperative Delirium in Cardiac Surgery Patients. Clin Ther. 2015 Dec 1;37(12):2686-2699.e9. doi: 10.1016/j.clinthera.2015.10.021. Epub 2015 Nov 29.

  PMID: 26621626 DERIVED

• Hori D, Brown C, Ono M, Rappold T, Sieber F, Gottschalk A, Neufeld KJ, Gottesman R, Adachi H, Hogue CW. Arterial pressure above the upper cerebral autoregulation limit during cardiopulmonary bypass is associated with postoperative delirium. Br J Anaesth. 2014 Dec;113(6):1009-17. doi: 10.1093/bja/aeu319. Epub 2014 Sep 25.

  PMID: 25256545 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Brain Injuries

Interventions

Homeostasis; Control Groups

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Limitations and Caveats

Limitations include missing data including unavoidable missing MRI data (retained temporary cardiac pacemaker leads, patient refusal and discharge prior to scheduled MRI. Patient refusal of completing cognitive tests. Enrollment period of 9 years.

Results Point of Contact

• Title: Paul C. Fitzgerald RN, BSN, MS
• Organization: Northwestern University

p-fitzgerald2@northwestern.edu

312-695-1064

Study Officials

• Charles Hogue, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2009
• First Posted: September 22, 2009
• Study Start: September 1, 2009
• Primary Completion: February 4, 2020
• Study Completion: February 28, 2020
• Last Updated: June 5, 2026
• Results First Posted: March 2, 2021

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)