Cerebral Autoregulation Monitoring During Cardiac Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00981474|
Recruitment Status : Active, not recruiting
First Posted : September 22, 2009
Last Update Posted : September 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Thoracic Surgery Cardiopulmonary Bypass||Drug: blood pressure maintenance based on cerebral blood flow autoregulation measurement Device: Control group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||490 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Continuous Cerebral Autoregulation Monitoring to Reduce Brain Injury From Cardiac Surgery|
|Actual Study Start Date :||September 1, 2009|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||September 30, 2020|
Active Comparator: Control
Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management.
Device: Control group
Institutional standard of care.
Blood pressure management based on cerebral autoregulation data.
Drug: 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. [ Time Frame: Perioperative ]
- Postoperative Delirium [ Time Frame: Postoperative days 1-4 ]Assessed with Confusion Assessment Method or Confusion Assessment Method-ICU along with adjudication by team of experts
- Blood Biomarker Delirium and Cognitive Relationships [ Time Frame: Immediate postopertive period and postoperative days 1-2 compared with baseline. ]Exploratory analysis evaluating for a relationship between experimental blood brain injury and homeostatic biomarkers and the cognitive and delirium assessments
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00981474
|United States, Illinois|
|Northwestern Memorial Hospital|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Charles Hogue, MD||Northwestern University|