Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
200 participants
INTERVENTIONAL
2022-03-02
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Anesthesia induction with Ketamine
Subjects will receive Ketamine to begin anesthesia for their cardiac surgery.
Ketamine
1-2 mg/kg induction with additional medication administered as needed to achieve intubating conditions
Anesthesia induction with Propofol
Subjects will receive Propofol to begin anesthesia for their cardiac surgery.
Propofol
0.5-1 mg/kg induction with additional medication administered as needed to achieve intubating conditions
Interventions
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Ketamine
1-2 mg/kg induction with additional medication administered as needed to achieve intubating conditions
Propofol
0.5-1 mg/kg induction with additional medication administered as needed to achieve intubating conditions
Eligibility Criteria
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Inclusion Criteria
* Scheduled to undergo complex cardiac surgery with the use of cardiopulmonary bypass. Complex cardiac surgery will be defined as surgery involving more than one heart valve, redo-sternotomy procedures, or combined valvular and coronary artery bypass graft procedures (aortic repair not excluded if meets other criteria).
Exclusion Criteria
* Procedures not requiring cardiopulmonary bypass.
* Active infection or sepsis requiring antimicrobial therapy and/or vasopressor therapy (treated endocarditis is not excluded).
* Severe hepatic disease resulting in ascites.
* Pre-operative significant renal dysfunction including a baseline creatinine equal to or greater than 2 mg/dL or requiring dialysis.
* Immunosuppressive medication use (including current IV or oral steroids use, use of anti-rejection medications for transplant within 1 month, or chemotherapy within 6 months).
* Immunodeficiency syndrome including HIV/AIDS, leukemia, and multiple myeloma
70 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Erica D. Wittwer, M.D., Ph.D.
Principal Investigator
Principal Investigators
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Erica D Wittwer, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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21-004327
Identifier Type: -
Identifier Source: org_study_id
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