Status:
UNKNOWN
Cerebral Monitor Guided Therapy on Cerebral Outcomes After Cardiac Surgery
Lead Sponsor:
University of Washington
Conditions:
Cardiac Surgery
Protein Metabolomics
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare patients' metabolomic profiles who are managed with a brain monitor that measures cerebral oxygen to those who are managed by conventional measures to hopefully...
Detailed Description
Neurologic and cognitive decline remain common complications that adversely affect patients' outcome after cardiac surgery. By incorporating a brain monitor that measures cerebral oxygen content into ...
Eligibility Criteria
Inclusion
- Adult cardiac surgery patients undergoing cardio-pulmonary bypass (CPB) with cardioplegic arrest (CABG, valves, CABG + valves).
Exclusion
- History of a stroke within 90 days prior to enrollment, or a history of cerebral vascular disease with significant (\> 80%) extra cranial stenosis;
- Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator;
- Existence of any ongoing mechanical circulatory support other than intra- aortic balloon counter pulsation;
- Body Mass Index (BMI) \> 50 kg/m2;
- Pregnancy;
- Psychiatric disease, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol;
- Presence of active, uncontrolled infection;
- Evidence of intrinsic hepatic disease as defined by liver enzyme values;
- Participation in any other clinical investigation that is likely to confound study results or affect study outcome;
- Patient refuses to be enrolled in study;
- Institution inmates
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03316183
Start Date
December 1 2021
End Date
December 1 2025
Last Update
February 23 2021
Active Locations (1)
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1
University of Washington Medical Center
Seattle, Washington, United States, 98195