Cerebral Monitor Guided Therapy on Cerebral Outcomes After Cardiac Surgery
Status unconfirmed · Not applicable
Conditions studied: Cardiac Surgery, Protein Metabolomics, Cerebral Function, Cardiopulmonary Bypass
In brief
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 decrease postoperative neurologic and cognitive deficits and improve quality of life.
Key facts
- Study ID
- NCT03316183
- Run by
- University of Washington
- People needed
- 20
- Starts
- 2021-12-01
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2021-02-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult cardiac surgery patients undergoing cardio-pulmonary bypass (CPB) with cardioplegic arrest (CABG, valves, CABG + valves).
You may not qualify if…
- 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
Where it is running
- University of Washington Medical Center — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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