Ketamine and Kidney Injury in Cardiac Surgery

Phase 4

Recruiting

• Conditions: Cardiac Surgery
• Interventions: Drug: Ketamine; Drug: Propofol

• Registration Number: NCT05268562
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-08
• Study Start: 2022-03-02
• Study First Submitted QC: 2022-03-04
• Study First Posted: 2022-03-07
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-08
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anesthesia induction with Ketamine	Ketamine	Subjects will receive Ketamine to begin anesthesia for their cardiac surgery.
Anesthesia induction with Propofol	Propofol	Subjects will receive Propofol to begin anesthesia for their cardiac surgery.

Primary Outcome Measures

Name	Time	Method
Acute Kidney Injury	Immediately postop up to 10 days postoperatively	The incidence of acute kidney injury in patients following cardiac surgery

Secondary Outcome Measures

Name	Time	Method
Vasopressor use	Immediately post induction up to 30 minute following induction	Compare mean total vasopressor doses, in norepinephrine equivalents, between groups following induction as a surrogate for hemodynamic differences

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States