Ketamine and Kidney Injury in Cardiac Surgery

NCT05268562 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 21-004327
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery

Keywords

Cardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

• Acute Kidney Injury

  The incidence of acute kidney injury in patients following cardiac surgery

  Immediately postop up to 10 days postoperatively

Secondary Outcomes (1)

• Vasopressor use

  Immediately post induction up to 30 minute following induction

Study Arms (2)

Anesthesia induction with Ketamine

ACTIVE COMPARATOR

Subjects will receive Ketamine to begin anesthesia for their cardiac surgery.

Drug: Ketamine

Anesthesia induction with Propofol

ACTIVE COMPARATOR

Subjects will receive Propofol to begin anesthesia for their cardiac surgery.

Drug: Propofol

Interventions

Ketamine DRUG

1-2 mg/kg induction with additional medication administered as needed to achieve intubating conditions

Anesthesia induction with Ketamine

Propofol DRUG

0.5-1 mg/kg induction with additional medication administered as needed to achieve intubating conditions

Anesthesia induction with Propofol

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Ketamine; Propofol

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic

Study Officials

• Erica D Wittwer, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: March 7, 2022
• Study Start: March 2, 2022
• Primary Completion: September 5, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-08

Locations

US (1)