Ketamine and Kidney Injury in Cardiac Surgery
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 21-004327
NCT ID: NCT05268562
About this study
The purpose of this study is to investigate cardiac surgical procedures requiring cardiopulmonary bypass (CPB). Ketamine has been demonstrated to have an anti-inflammatory effect as shown by reductions in Interleukin 6 (IL-6) levels. Postoperative dysfunctions in which inflammation has been implicated may be reduced by this anti-inflammatory effect. Use of inotropic and vasopressor support, hemodynamic variables, incidence of renal dysfunction, and effect on biomarkers of renal function in the early postoperative period. Specifically, we will test the hypothesis that ketamine provides anti-inflammatory effects in this population of patients undergoing surgery requiring CPB and that the incidence of renal dysfunction will be decreased.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 2/15/23. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available