Thoracic SurgeryNCT00981474
Cerebral Autoregulation Monitoring During Cardiac Surgery
A study testing blood pressure maintenance based on cerebral blood flow autoregulation measurement in people with Thoracic Surgery and Cardiopulmonary Bypass, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Thoracic Surgery, Cardiopulmonary Bypass
- What is being tested?
- blood pressure maintenance based on cerebral blood flow autoregulation measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2009to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: Continuous Cerebral Autoregulation Monitoring to Reduce Brain Injury From Cardiac Surgery
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.
Read the detailed description
Brain injury during cardiac surgery results primarily from cerebral embolism and/or reduced cerebral blood flow (CBF). The latter is of particular concern for the growing number of surgical patients who are aged and/or who have cerebral vascular disease. Normally, CBF is physiologically autoregulated (or kept constant) within a range of blood pressures allowing for stable cerebral O2 supply commensurate with metabolic demands. Cerebral autoregulation is impaired in patients undergoing cardiac surgery who have cerebral vascular disease and in many others due to other conditions. This could lead to brain injury since current practices of targeting low mean arterial blood pressure empirically (usually 50-70 mmHg) during cardiopulmonary bypass may expose patients with impaired cerebral autoregulation to cerebral hypoperfusion. The hypothesis of this proposal is that targeting mean arterial pressure during cardiopulmonary bypass to a level above an individual's lower autoregulatory threshold reduces the risk for brain injury in patients undergoing cardiac surgery. Monitoring of cerebral autoregulation will be performed in real time using software that continuously compares the relation between arterial blood pressure and CBF velocity of the middle cerebral artery measured with transcranial Doppler and with cerebral oximetry measured with near infrared spectroscopy. The primary end-point of the study will be a comprehensive composite outcome of clinical stroke, cognitive decline, and/or new ischemic brain lesions detected with diffusion weighted magnetic resonance (MR) imaging. Delirium assessed using a validated procedure that includes validated tools is a secondary outcome measure. Autoregulation is mediated by reactivity of cerebral resistance vessels. A secondary aim of this proposal is to evaluate whether near infrared reflectance spectroscopy can be used to trend changes in cerebral blood volume and provide a reliable monitor of vascular reactivity (the hemoglobin volume index). Assessments for extra-cranial and intra-cranial arterial stenosis will be performed using MR angiography to control for this potential confounding variable in the analysis. Finally, an additional aim of the study will be to assess whether preoperative transcranial Doppler examination of major cerebral arteries can identify patients who are prone to the composite neurological end-point. Near infrared oximetry is non-invasive, continuous, requires little care-giver intervention and, thus, could be widely used to individualize patient blood pressure management during surgery. Brain injury from cardiac surgery is an important source of operative mortality, prolonged hospitalization, increased health care expenditure, and impaired quality of life. Developing strategies to reduce the burden of this complication has wide public health implications.
- Conditions
- Thoracic Surgery, Cardiopulmonary Bypass
- Being tested
- blood pressure maintenance based on cerebral blood flow autoregulation measurement, Control group
- Keywords
- cardiac surgery; brain injury; cerebral autoregulation
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood pressure maintenance based on cerebral blood flow autoregulation measurementDrug
Also called Autoregulation
Blood pressure lowered or raised
Control groupDevice
Also called Usual (Control Group)
Institutional standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management. Receives: Device: Control group |
| Intervention | Experimental | Blood pressure management based on cerebral autoregulation data. Receives: Drug: blood pressure maintenance based on cerebral blood flow autoregulation measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 weeks post-operative
Secondary outcomes (10)
Postoperative Delirium
Assessed with Confusion Assessment Method or Confusion Assessment Method-ICU along with adjudication by team of experts
Measured: Postoperative days 1-4
Multiple Inotropic Drugs>24 Hours After Surgery
Use of multiple inotropic drugs greater than 24 hours after the planned surgical procedure until discharge from the hospital.
Measured: 7 days after surgery
Mechanical Lung Ventilation>24 Hours After Surgery
Subjects need for mechanical lung ventilation more than 24 hours after planned surgical procedure.
Measured: Up to 28 days after surgery.
Insertion of Intra-aortic Balloon Pump
Procedural insertion of intra-aortic balloon pump within 7 days after surgical procedure
Measured: 7 days after surgery
Postoperative Atrial Fibrillation
Clinical diagnosis of postoperative atrial fibrillation from date of surgical procedure to discharge from the hospital.
Measured: Up to 28 days after surgery.
Sepsis
Clinical diagnosis of sepsis from time of surgical procedure to discharge from the hospital.
Measured: Up to 28 days after surgery.
Acute Kidney Injury Within 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.
Measured: 7 days after surgery
New Renal Replacement Therapy
Subjects requiring new renal replacement therapy prior to discharge from hospital
Measured: Up to 28 days after surgery.
Multisystem Organ Failure After Surgery
Subject diagnosis of multisystem organ failure after surgery.
Measured: Up to 28 days after surgery.
Mortality
Subject death within 28 days after surgical procedure
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study start1 Sep 2009
- Primary completion4 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Charles Hogue, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981474
- Sponsor's protocol ID
- 680
- Other IDs
- 1R01HL092259
- Status last verified
- May 2026
- First submitted
- 21 Sep 2009
- Last updated
- 5 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hogue CW Jr, Palin CA, Arrowsmith JE. Cardiopulmonary bypass management and neurologic outcomes: an evidence-based appraisal of current practices. Anesth Analg. 2006 Jul;103(1):21-37. doi: 10.1213/01.ANE.0000220035.82989.79.
PubMed 16790619Gottesman 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.
PubMed 17562924Gottesman 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.
PubMed 16857947Nomura 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.
PubMed 29677060Czosnyka 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.
PubMed 19127448Brady 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.
PubMed 20651274Piechnik SK, Yang X, Czosnyka M, Smielewski P, Fletcher SH, Jones AL, Pickard JD. The continuous assessment of cerebrovascular reactivity: a validation of the method in healthy volunteers. Anesth Analg. 1999 Oct;89(4):944-9. doi: 10.1097/00000539-199910000-00023.
PubMed 10512269Kneebone AC, Andrew MJ, Baker RA, Knight JL. Neuropsychologic changes after coronary artery bypass grafting: use of reliable change indices. Ann Thorac Surg. 1998 May;65(5):1320-5. doi: 10.1016/s0003-4975(98)00158-1.
PubMed 9594860Brown CH 4th, Probert J, Healy R, Parish M, Nomura Y, Yamaguchi A, Tian J, Zehr K, Mandal K, Kamath V, Neufeld KJ, Hogue CW. Cognitive Decline after Delirium in Patients Undergoing Cardiac Surgery. Anesthesiology. 2018 Sep;129(3):406-416. doi: 10.1097/ALN.0000000000002253.
PubMed 29771710Brown 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.
PubMed 31116358Goldstein LB, Bertels C, Davis JN. Interrater reliability of the NIH stroke scale. Arch Neurol. 1989 Jun;46(6):660-2. doi: 10.1001/archneur.1989.00520420080026.
PubMed 2730378Evered 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.
PubMed 29156035Kellum 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.
PubMed 23394211Lameire 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.
PubMed 23394215Mathew 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.
PubMed 19164788
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Cerebral Autoregulation Monitoring to Reduce Brain Injury From Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00981474
- Acronym / sponsor ID
- 680
- Conditions
- Thoracic Surgery, Cardiopulmonary Bypass
- Keywords
- cardiac surgery; brain injury; cerebral autoregulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Sep 2009 (actual)
- Primary completion
- 4 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 22 Sep 2009 (estimated)
- Results
- Posted 2 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Brain injury during cardiac surgery results primarily from cerebral embolism and/or reduced cerebral blood flow (CBF). The latter is of particular concern for the growing number of surgical patients who are aged and/or who have cerebral vascular disease. Normally, CBF is physiologically autoregulated (or kept constant) within a range of blood pressures allowing for stable cerebral O2 supply commensurate with metabolic demands. Cerebral autoregulation is impaired in patients undergoing cardiac surgery who have cerebral vascular disease and in many others due to other conditions. This could lead to brain injury since current practices of targeting low mean arterial blood pressure empirically (usually 50-70 mmHg) during cardiopulmonary bypass may expose patients with impaired cerebral autoregulation to cerebral hypoperfusion. The hypothesis of this proposal is that targeting mean arterial pressure during cardiopulmonary bypass to a level above an individual's lower autoregulatory threshold reduces the risk for brain injury in patients undergoing cardiac surgery. Monitoring of cerebral autoregulation will be performed in real time using software that continuously compares the relation between arterial blood pressure and CBF velocity of the middle cerebral artery measured with transcranial Doppler and with cerebral oximetry measured with near infrared spectroscopy. The primary end-point of the study will be a comprehensive composite outcome of clinical stroke, cognitive decline, and/or new ischemic brain lesions detected with diffusion weighted magnetic resonance (MR) imaging. Delirium assessed using a validated procedure that includes validated tools is a secondary outcome measure. Autoregulation is mediated by reactivity of cerebral resistance vessels. A secondary aim of this proposal is to evaluate whether near infrared reflectance spectroscopy can be used to trend changes in cerebral blood volume and provide a reliable monitor of vascular reactivity (the hemoglobin volume index). Assessments for extra-cranial and intra-cranial arterial stenosis will be performed using MR angiography to control for this potential confounding variable in the analysis. Finally, an additional aim of the study will be to assess whether preoperative transcranial Doppler examination of major cerebral arteries can identify patients who are prone to the composite neurological end-point. Near infrared oximetry is non-invasive, continuous, requires little care-giver intervention and, thus, could be widely used to individualize patient blood pressure management during surgery. Brain injury from cardiac surgery is an important source of operative mortality, prolonged hospitalization, increased health care expenditure, and impaired quality of life. Developing strategies to reduce the burden of this complication has wide public health implications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: Control groupBlood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management. |
| Intervention | Experimental | Drug: blood pressure maintenance based on cerebral blood flow autoregulation measurementBlood pressure management based on cerebral autoregulation data. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood pressure maintenance based on cerebral blood flow autoregulation measurementAlso: AutoregulationBlood pressure lowered or raised | Drug | Intervention |
| Control groupAlso: Usual (Control Group)Institutional standard of care. | Device | Control |
Primary outcome
Composite Neurological Outcome of Clinical Stroke or New Ischemic Brain Lesion on Diffusion Weighted MRI or Neurocognitive Dysfunction 4 to 6 Weeks After Surgery.
Time frame: Up to 6 weeks post-operative
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.
10 secondary outcomes
Postoperative Delirium
Time frame: Postoperative days 1-4
Multiple Inotropic Drugs>24 Hours After Surgery
Time frame: 7 days after surgery
Mechanical Lung Ventilation>24 Hours After Surgery
Time frame: Up to 28 days after surgery.
Insertion of Intra-aortic Balloon Pump
Time frame: 7 days after surgery
Postoperative Atrial Fibrillation
Time frame: Up to 28 days after surgery.
Sepsis
Time frame: Up to 28 days after surgery.
Acute Kidney Injury Within 7 Days After Surgery.
Time frame: 7 days after surgery
New Renal Replacement Therapy
Time frame: Up to 28 days after surgery.
Multisystem Organ Failure After Surgery
Time frame: Up to 28 days after surgery.
Mortality
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16790619Hogue CW Jr, Palin CA, Arrowsmith JE. Cardiopulmonary bypass management and neurologic outcomes: an evidence-based appraisal of current practices. Anesth Analg. 2006 Jul;103(1):21-37. doi: 10.1213/01.ANE.0000220035.82989.79.
- Background: PubMed 17562924Gottesman 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.
- Background: PubMed 16857947Gottesman 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.
- Background: PubMed 29677060Nomura 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.
- Background: PubMed 19127448Czosnyka 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.
- Background: PubMed 20651274Brady 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.
- Background: PubMed 10512269Piechnik SK, Yang X, Czosnyka M, Smielewski P, Fletcher SH, Jones AL, Pickard JD. The continuous assessment of cerebrovascular reactivity: a validation of the method in healthy volunteers. Anesth Analg. 1999 Oct;89(4):944-9. doi: 10.1097/00000539-199910000-00023.
- Background: PubMed 9594860Kneebone AC, Andrew MJ, Baker RA, Knight JL. Neuropsychologic changes after coronary artery bypass grafting: use of reliable change indices. Ann Thorac Surg. 1998 May;65(5):1320-5. doi: 10.1016/s0003-4975(98)00158-1.
- Background: PubMed 29771710Brown CH 4th, Probert J, Healy R, Parish M, Nomura Y, Yamaguchi A, Tian J, Zehr K, Mandal K, Kamath V, Neufeld KJ, Hogue CW. Cognitive Decline after Delirium in Patients Undergoing Cardiac Surgery. Anesthesiology. 2018 Sep;129(3):406-416. doi: 10.1097/ALN.0000000000002253.
- Background: PubMed 31116358Brown 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.
- Background: PubMed 2730378Goldstein LB, Bertels C, Davis JN. Interrater reliability of the NIH stroke scale. Arch Neurol. 1989 Jun;46(6):660-2. doi: 10.1001/archneur.1989.00520420080026.
- Background: PubMed 29156035Evered 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Hogue, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood pressure maintenance based on cerebral blood flow autoregulation measurement in people with Thoracic Surgery and Cardiopulmonary Bypass, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Neurological Outcome of Clinical Stroke or New Ischemic Brain Lesion on Diffusion Weighted MRI or Neurocognitive Dysfunction 4 to 6 Weeks After Surgery. (time frame: Up to 6 weeks post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00981474, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.