Impact of Ketamine Versus Propofol for Anesthetic Induction on Acute Kidney Injury and Renal Biomarkers in Cardiac Surgery
| Registry | NCT05268562 |
|---|---|
| Status | Active not recruiting |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: none, basic science |
| Enrollment | 200 (Actual) |
| Sponsor | Mayo Clinic (Other) |
| Conditions | Cardiac Surgery |
| Interventions | Ketamine, Propofol (Drug) |
| Dates | start 2022-03-02, primary completion 2025-09-05, completion 2027-06-01 (estimated), first posted 2022-03-07, last updated 2026-10-20 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Cardiac Surgery All trials of Ketamine All trials of Propofol
The purpose of this study is to investigate the affects of ketamine use for anesthesia at the beginning of heart surgery on kidneys compared to the use of propofol.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Anesthesia induction with Ketamine | Active comparator | Drug: Ketamine | Subjects will receive Ketamine to begin anesthesia for their cardiac surgery. |
| Anesthesia induction with Propofol | Active comparator | Drug: Propofol | Subjects will receive Propofol to begin anesthesia for their cardiac surgery. |
Sex: All, ages: 70 Years to any
Inclusion Criteria: * Presenting for cardiac surgery at the Mayo Clinic in Rochester, Minnesota. * 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: * Left or right ventricular assist device implantation or explantation. * 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
| Milestone | Anesthesia Induction With Ketamine | Anesthesia Induction With Propofol |
|---|---|---|
| Started | 100 | 100 |
| Completed | 89 | 97 |
| Not completed | 11 | 3 |
Time frame: Up until one week from surgery
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Anesthesia Induction With Ketamine | 0/89 (0.0%) | 0/89 (0.0%) | 0/89 (0.0%) |
| Anesthesia Induction With Propofol | 3/97 (3.1%) | 0/97 (0.0%) | 0/97 (0.0%) |
Limitations and caveats: Caveats: Initially intended to assess impact of renal biomarkers on ability to predict AKI however due to changes in cost over time as well as addition of some biomarkers as standard of care at a different time point, these were unable to be assessed. Limitations: The intervention, induction with one of two agents, could not be blinded from the anesthesiologists. This could allow for bias due to beliefs about impact of either medication to impact the amount given or additional therapies used.
| Facility | City | Country | Status |
|---|---|---|---|
| Mayo Clinic in Rochester | Rochester, Minnesota | United States |