Status:
COMPLETED
Cerebral Autoregulation Monitoring During Cardiac Surgery
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Thoracic Surgery
Cardiopulmonary Bypass
Eligibility:
All Genders
55+ years
Phase:
NA
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...
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 w...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2020
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT00981474
Start Date
September 1 2009
End Date
February 28 2020
Last Update
March 2 2021
Active Locations (1)
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1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611