Ketamine and Kidney Injury in Cardiac Surgery

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05268562
• Other study ID #: 21-004327
• Status: Recruiting
• Phase: Phase 4
• Start date: March 2, 2022
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Mayo Clinic
• Contact: Rhonda Synder
• Phone: 507-255-4487
• Email: Snyder.Rhonda[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Drug:
• Ketamine
1-2 mg/kg induction with additional medication administered as needed to achieve intubating conditions
• Propofol
0.5-1 mg/kg induction with additional medication administered as needed to achieve intubating conditions

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Kidney Injury	The incidence of acute kidney injury in patients following cardiac surgery	Immediately postop up to 10 days postoperatively
Secondary	Vasopressor use	Compare mean total vasopressor doses, in norepinephrine equivalents, between groups following induction as a surrogate for hemodynamic differences	Immediately post induction up to 30 minute following induction

External Links

•   Mayo Clinic Clinical Trials