Cerebral Autoregulation Monitoring During Cardiac Surgery
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|ClinicalTrials.gov Identifier: NCT00981474|
Recruitment Status : Recruiting
First Posted : September 22, 2009
Last Update Posted : March 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Thoracic Surgery Cardiopulmonary Bypass||Drug: blood pressure maintenance based on cerebral blood flow autoregulation measurement Drug: 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 :||June 1, 2019|
|Estimated Study Completion Date :||August 31, 2019|
Active Comparator: Control
Blood pressure targets during cardiopulmonary bypass based on institutional standards of empiric management.
Drug: 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 1-3 ]Assessed with Confusion Assessment Method or Confusion Assessment Method-ICU along with adjudication by team of experts
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
|Contact: Charles W Hogue, MDfirstname.lastname@example.org|
|United States, Illinois|
|Northwestern Memorial Hospital||Recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Paul Fitzgerral, BSN 312-926-2949 email@example.com|
|Principal Investigator: Charles W. Hogue, MD|