Ketamine and Kidney Injury in Cardiac Surgery

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT05268562

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Surgery	Drug: Ketamine Drug: Propofol	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Impact of Ketamine Versus Propofol for Anesthetic Induction on Acute Kidney Injury and Renal Biomarkers in Cardiac Surgery

Actual Study Start Date :

Mar 2, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Anesthesia induction with Ketamine Subjects will receive Ketamine to begin anesthesia for their cardiac surgery.	Drug: Ketamine 1-2 mg/kg induction with additional medication administered as needed to achieve intubating conditions
Active Comparator: Anesthesia induction with Propofol Subjects will receive Propofol to begin anesthesia for their cardiac surgery.	Drug: Propofol 0.5-1 mg/kg induction with additional medication administered as needed to achieve intubating conditions

Arm

Intervention/Treatment

Active Comparator: Anesthesia induction with Ketamine

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

Drug: Ketamine

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

Active Comparator: Anesthesia induction with Propofol

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

Drug: Propofol

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Erica D Wittwer, MD, PhD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Erica D. Wittwer, M.D., Ph.D., Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT05268562

Other Study ID Numbers:

21-004327

First Posted:

Mar 7, 2022

Last Update Posted:

Mar 7, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Erica D. Wittwer, M.D., Ph.D., Principal Investigator, Mayo Clinic

Cardiopulmonary bypass

Additional relevant MeSH terms:

Ketamine

Propofol

Study Results

No Results Posted as of Mar 7, 2022