Trial Outcomes & Findings for Cerebral Autoregulation Monitoring During Cardiac Surgery (NCT NCT00981474)

Last Updated: 2026-06-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

460 participants

Primary outcome timeframe

Up to 6 weeks post-operative

Results posted on

2026-06-05

Participant Flow

After obtaining written informed consent, 468 were randomized to the two groups. 237 in the autoregulation group were randomized after consent and 5 subjects withdrew consent. 231 in the usual care group were randomized after consent and 3 subjects withdrew consent.

Participant milestones

Participant milestones
Measure	Usual Care Group (Control) Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management. Control group: Institutional standard of care.	Autoregulation Group Blood pressure management based on cerebral autoregulation data. blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised
Overall Study STARTED	228	232
Overall Study COMPLETED	228	232
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cerebral Autoregulation Monitoring During Cardiac Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care Group n=228 Participants Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management. Control group: Institutional standard of care.	Autoregulation Group n=232 Participants Blood pressure management based on cerebral autoregulation data. blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised	Total n=460 Participants Total of all reporting groups
Age, Continuous	70.8 years STANDARD_DEVIATION 8.0 • n=20 Participants	70.0 years STANDARD_DEVIATION 7.3 • n=20 Participants	70.4 years STANDARD_DEVIATION 7.6 • n=40 Participants
Sex/Gender, Customized Female	67 participants n=20 Participants	62 participants n=20 Participants	129 participants n=40 Participants
Sex/Gender, Customized Male	160 participants n=20 Participants	170 participants n=20 Participants	330 participants n=40 Participants
Sex/Gender, Customized Missing designation	1 participants n=20 Participants	0 participants n=20 Participants	1 participants n=40 Participants
Race/Ethnicity, Customized Caucasian	189 participants n=20 Participants	184 participants n=20 Participants	273 participants n=40 Participants
Race/Ethnicity, Customized African American	24 participants n=20 Participants	28 participants n=20 Participants	52 participants n=40 Participants
Race/Ethnicity, Customized Hispanic	3 participants n=20 Participants	2 participants n=20 Participants	5 participants n=40 Participants
Race/Ethnicity, Customized Native American	1 participants n=20 Participants	3 participants n=20 Participants	4 participants n=40 Participants
Race/Ethnicity, Customized Asian	0 participants n=20 Participants	4 participants n=20 Participants	4 participants n=40 Participants
Race/Ethnicity, Customized Multiple	0 participants n=20 Participants	2 participants n=20 Participants	2 participants n=40 Participants
Race/Ethnicity, Customized Other	10 participants n=20 Participants	9 participants n=20 Participants	19 participants n=40 Participants
Region of Enrollment United States	228 Participants n=20 Participants	232 Participants n=20 Participants	460 Participants n=40 Participants
Highest Grade of Formal Education (median,[inter-quartile range])	14.0 Years n=20 Participants	14.5 Years n=20 Participants	14 Years n=40 Participants
Mini-Mental State Exam	28 score on a scale (30 good- 0 poor) n=20 Participants	28 score on a scale (30 good- 0 poor) n=20 Participants	28 score on a scale (30 good- 0 poor) n=40 Participants
History of a prior stroke	25 Participants n=20 Participants	19 Participants n=20 Participants	44 Participants n=40 Participants
History of hypertension	213 Participants n=20 Participants	207 Participants n=20 Participants	420 Participants n=40 Participants
History of atrial fibrillation	53 Participants n=20 Participants	49 Participants n=20 Participants	102 Participants n=40 Participants
History of myocardial infarction	65 Participants n=20 Participants	74 Participants n=20 Participants	139 Participants n=40 Participants
History of chronic obstructive lung disease	31 Participants n=20 Participants	21 Participants n=20 Participants	52 Participants n=40 Participants
Obstructive sleep apnea	41 Participants n=20 Participants	36 Participants n=20 Participants	77 Participants n=40 Participants
Current tobacco use	22 Participants n=20 Participants	24 Participants n=20 Participants	46 Participants n=40 Participants
History of diabetes	101 Participants n=20 Participants	108 Participants n=20 Participants	209 Participants n=40 Participants
History of anemia	101 Participants n=20 Participants	108 Participants n=20 Participants	209 Participants n=40 Participants
Logistic EuroSCORE (median,[interquartile range])	5.3 score on a scale 0-2 good >=5 high risk n=20 Participants	5.08 score on a scale 0-2 good >=5 high risk n=20 Participants	5.19 score on a scale 0-2 good >=5 high risk n=40 Participants
Cardiopulmonary bypass duration	107 Minutes n=20 Participants	103 Minutes n=20 Participants	105 Minutes n=40 Participants
Type of surgery Coronary Artery Bypass Graft (CABG)	109 Participants n=20 Participants	117 Participants n=20 Participants	226 Participants n=40 Participants
Type of surgery Coronary Aertery Bypass Graft, Aortic Valve Replacement (CABG/AVR)	35 Participants n=20 Participants	26 Participants n=20 Participants	61 Participants n=40 Participants
Type of surgery Coronary Artery Bypass Graft, Mitral Valve Replacement CABG/MVR)	6 Participants n=20 Participants	9 Participants n=20 Participants	15 Participants n=40 Participants
Type of surgery Coronary Artery Bypass Graft, Aortic Valve Replacement, Mitral Valve Replacement (CABG/AVR/MVR)	3 Participants n=20 Participants	3 Participants n=20 Participants	6 Participants n=40 Participants
Type of surgery Aortic Valve Replacement (AVR)	41 Participants n=20 Participants	48 Participants n=20 Participants	89 Participants n=40 Participants
Type of surgery Mitral Valve Replacement (MVR)	19 Participants n=20 Participants	22 Participants n=20 Participants	41 Participants n=40 Participants
Type of surgery Aortic Valve Replacement, Mitral Valve Replacement (AVR/MVR)	9 Participants n=20 Participants	5 Participants n=20 Participants	14 Participants n=40 Participants
Type of surgery Aortic Root Replacement	2 Participants n=20 Participants	2 Participants n=20 Participants	4 Participants n=40 Participants
Type of surgery Coronary Artery Bypass Graft, (CABG) / Aortic Root Replacement	1 Participants n=20 Participants	0 Participants n=20 Participants	1 Participants n=40 Participants
Type of surgery Transcatheter Aortic Valve Replacement (TAVR)	3 Participants n=20 Participants	0 Participants n=20 Participants	3 Participants n=40 Participants
Aortic cross-clamp (time in minutes)	73 Minutes n=20 Participants	69 Minutes n=20 Participants	71 Minutes n=40 Participants
Duration of ICU admission (hours)	44.1 Hours n=20 Participants	44 Hours n=20 Participants	44 Hours n=40 Participants
Duration of hospitalization (days)	8 Days n=20 Participants	7 Days n=20 Participants	7 Days n=40 Participants

PRIMARY outcome

Timeframe: Up to 6 weeks post-operative

Population: Subjects who completed neurological testing and MRI testing

Outcome measures

Outcome measures
Measure	Control n=101 Participants Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management. Control group: Institutional standard of care.	Autoregulation Group n=93 Participants Blood pressure management based on cerebral autoregulation data. blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised
Composite Neurological Outcome of Clinical Stroke or New Ischemic Brain Lesion on Diffusion Weighted MRI or Neurocognitive Dysfunction 4 to 6 Weeks After Surgery.	79 Participants	70 Participants

SECONDARY outcome

Timeframe: Postoperative days 1-4

Population: Delirium was measured day 1-4. 232 in the autoregulation group were assessed and 228 were assessed in the usual care group.

Assessed with Confusion Assessment Method or Confusion Assessment Method-ICU along with adjudication by team of experts

Outcome measures

Outcome measures
Measure	Control n=228 Participants Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management. Control group: Institutional standard of care.	Autoregulation Group n=232 Participants Blood pressure management based on cerebral autoregulation data. blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised
Postoperative Delirium	34 Participants	19 Participants

SECONDARY outcome

Timeframe: 7 days after surgery

Population: 228 in the usual care group and 232 in the autoregulation group were analyzed.

Use of multiple inotropic drugs greater than 24 hours after the planned surgical procedure until discharge from the hospital.

Outcome measures

Outcome measures
Measure	Control n=228 Participants Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management. Control group: Institutional standard of care.	Autoregulation Group n=232 Participants Blood pressure management based on cerebral autoregulation data. blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised
Multiple Inotropic Drugs>24 Hours After Surgery	13 participants	6 participants

SECONDARY outcome

Timeframe: Up to 28 days after surgery.

Subjects need for mechanical lung ventilation more than 24 hours after planned surgical procedure.

Outcome measures

Outcome measures
Measure	Control n=228 Participants Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management. Control group: Institutional standard of care.	Autoregulation Group n=232 Participants Blood pressure management based on cerebral autoregulation data. blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised
Mechanical Lung Ventilation>24 Hours After Surgery	22 Participants	13 Participants

SECONDARY outcome

Timeframe: 7 days after surgery

Procedural insertion of intra-aortic balloon pump within 7 days after surgical procedure

Outcome measures

Outcome measures
Measure	Control n=228 Participants Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management. Control group: Institutional standard of care.	Autoregulation Group n=232 Participants Blood pressure management based on cerebral autoregulation data. blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised
Insertion of Intra-aortic Balloon Pump	19 Participants	14 Participants

SECONDARY outcome

Timeframe: Up to 28 days after surgery.

Clinical diagnosis of postoperative atrial fibrillation from date of surgical procedure to discharge from the hospital.

Outcome measures

Outcome measures
Measure	Control n=228 Participants Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management. Control group: Institutional standard of care.	Autoregulation Group n=232 Participants Blood pressure management based on cerebral autoregulation data. blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised
Postoperative Atrial Fibrillation	89 Participants	79 Participants

SECONDARY outcome

Timeframe: Up to 28 days after surgery.

Clinical diagnosis of sepsis from time of surgical procedure to discharge from the hospital.

Outcome measures

Outcome measures
Measure	Control n=228 Participants Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management. Control group: Institutional standard of care.	Autoregulation Group n=232 Participants Blood pressure management based on cerebral autoregulation data. blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised
Sepsis	7 Participants	2 Participants

SECONDARY outcome

Timeframe: 7 days after surgery

Subject developed acute kidney injury within 7 days after surgical procedure. Based on Kidney disease: Improving Global Outcomes (KDIGO) classification system.

Outcome measures

Outcome measures
Measure	Control n=228 Participants Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management. Control group: Institutional standard of care.	Autoregulation Group n=232 Participants Blood pressure management based on cerebral autoregulation data. blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised
Acute Kidney Injury Within 7 Days After Surgery.	56 Participants	62 Participants

SECONDARY outcome

Timeframe: Up to 28 days after surgery.

Subjects requiring new renal replacement therapy prior to discharge from hospital

Outcome measures

Outcome measures
Measure	Control n=228 Participants Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management. Control group: Institutional standard of care.	Autoregulation Group n=232 Participants Blood pressure management based on cerebral autoregulation data. blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised
New Renal Replacement Therapy	6 Participants	4 Participants

SECONDARY outcome

Timeframe: Up to 28 days after surgery.

Subject diagnosis of multisystem organ failure after surgery.

Outcome measures

Outcome measures
Measure	Control n=228 Participants Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management. Control group: Institutional standard of care.	Autoregulation Group n=232 Participants Blood pressure management based on cerebral autoregulation data. blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised
Multisystem Organ Failure After Surgery	7 Participants	2 Participants

SECONDARY outcome

Timeframe: 28 days

Subject death within 28 days after surgical procedure

Outcome measures

Outcome measures
Measure	Control n=228 Participants Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management. Control group: Institutional standard of care.	Autoregulation Group n=232 Participants Blood pressure management based on cerebral autoregulation data. blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised
Mortality	12 Participants	5 Participants

Adverse Events

Usual Care Group (Control)

Serious events: 133 serious events

Other events: 34 other events

Deaths: 12 deaths

Autoregulation Group

Serious events: 121 serious events

Other events: 19 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Usual Care Group (Control) n=228 participants at risk Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management. Control group: Institutional standard of care.	Autoregulation Group n=232 participants at risk Blood pressure management based on cerebral autoregulation data. Blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised
Renal and urinary disorders Acute Kidney Injury	24.6% 56/228 • Number of events 56 • Data were collected over a period of 1 year. Postoperative complications were based on the Society of Thoracic Surgery National Cardiac Surgery Database definitions (www.sts.org) as safety outcomes.	26.7% 62/232 • Number of events 62 • Data were collected over a period of 1 year. Postoperative complications were based on the Society of Thoracic Surgery National Cardiac Surgery Database definitions (www.sts.org) as safety outcomes.
General disorders Multisystem Organ Failure after Surgery	2.6% 6/228 • Number of events 6 • Data were collected over a period of 1 year. Postoperative complications were based on the Society of Thoracic Surgery National Cardiac Surgery Database definitions (www.sts.org) as safety outcomes.	1.7% 4/232 • Number of events 4 • Data were collected over a period of 1 year. Postoperative complications were based on the Society of Thoracic Surgery National Cardiac Surgery Database definitions (www.sts.org) as safety outcomes.
Blood and lymphatic system disorders Sepsis	3.1% 7/228 • Number of events 7 • Data were collected over a period of 1 year. Postoperative complications were based on the Society of Thoracic Surgery National Cardiac Surgery Database definitions (www.sts.org) as safety outcomes.	0.86% 2/232 • Number of events 2 • Data were collected over a period of 1 year. Postoperative complications were based on the Society of Thoracic Surgery National Cardiac Surgery Database definitions (www.sts.org) as safety outcomes.
Nervous system disorders Clinical Stroke	3.9% 9/228 • Number of events 9 • Data were collected over a period of 1 year. Postoperative complications were based on the Society of Thoracic Surgery National Cardiac Surgery Database definitions (www.sts.org) as safety outcomes.	5.6% 13/232 • Number of events 13 • Data were collected over a period of 1 year. Postoperative complications were based on the Society of Thoracic Surgery National Cardiac Surgery Database definitions (www.sts.org) as safety outcomes.
Nervous system disorders New Ischemic Lesions in Brian	55.3% 47/85 • Number of events 47 • Data were collected over a period of 1 year. Postoperative complications were based on the Society of Thoracic Surgery National Cardiac Surgery Database definitions (www.sts.org) as safety outcomes.	60.8% 48/79 • Number of events 48 • Data were collected over a period of 1 year. Postoperative complications were based on the Society of Thoracic Surgery National Cardiac Surgery Database definitions (www.sts.org) as safety outcomes.
General disorders Delayed Neurocognitive Recovery	21.3% 35/164 • Number of events 35 • Data were collected over a period of 1 year. Postoperative complications were based on the Society of Thoracic Surgery National Cardiac Surgery Database definitions (www.sts.org) as safety outcomes.	15.7% 27/172 • Number of events 27 • Data were collected over a period of 1 year. Postoperative complications were based on the Society of Thoracic Surgery National Cardiac Surgery Database definitions (www.sts.org) as safety outcomes.

Other adverse events

Other adverse events
Measure	Usual Care Group (Control) n=228 participants at risk Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management. Control group: Institutional standard of care.	Autoregulation Group n=232 participants at risk Blood pressure management based on cerebral autoregulation data. Blood pressure maintenance based on cerebral blood flow autoregulation measurement: Blood pressure lowered or raised
Psychiatric disorders Clinically detected delirium	14.9% 34/228 • Number of events 34 • Data were collected over a period of 1 year. Postoperative complications were based on the Society of Thoracic Surgery National Cardiac Surgery Database definitions (www.sts.org) as safety outcomes.	8.2% 19/232 • Number of events 19 • Data were collected over a period of 1 year. Postoperative complications were based on the Society of Thoracic Surgery National Cardiac Surgery Database definitions (www.sts.org) as safety outcomes.

Additional Information

Paul C. Fitzgerald RN, BSN, MS

Northwestern University

Phone: 312-695-1064

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place