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Ketamine and Kidney Injury in Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT05268562
Recruitment Status : Recruiting
First Posted : March 7, 2022
Last Update Posted : March 7, 2022
Sponsor:
Information provided by (Responsible Party):
Erica D. Wittwer, M.D., Ph.D., Mayo Clinic

Tracking Information
First Submitted Date  ICMJE February 8, 2022
First Posted Date  ICMJE March 7, 2022
Last Update Posted Date March 7, 2022
Actual Study Start Date  ICMJE March 2, 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2022)		 Acute Kidney Injury [ Time Frame: Immediately postop up to 10 days postoperatively ]
The incidence of acute kidney injury in patients following cardiac surgery
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2022)		 Vasopressor use [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine and Kidney Injury in Cardiac Surgery
Official Title  ICMJE Impact of Ketamine Versus Propofol for Anesthetic Induction on Acute Kidney Injury and Renal Biomarkers in Cardiac Surgery
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Cardiac Surgery
Intervention  ICMJE
  • Drug: Ketamine
    1-2 mg/kg induction with additional medication administered as needed to achieve intubating conditions
  • Drug: Propofol
    0.5-1 mg/kg induction with additional medication administered as needed to achieve intubating conditions
Study Arms  ICMJE
  • Active Comparator: Anesthesia induction with Ketamine
    Subjects will receive Ketamine to begin anesthesia for their cardiac surgery.
    Intervention: Drug: Ketamine
  • Active Comparator: Anesthesia induction with Propofol
    Subjects will receive Propofol to begin anesthesia for their cardiac surgery.
    Intervention: Drug: Propofol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 4, 2022)		 200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rhonda Synder 507-255-4487 Snyder.Rhonda@mayo.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05268562
Other Study ID Numbers  ICMJE 21-004327
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Erica D. Wittwer, M.D., Ph.D., Mayo Clinic
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Mayo Clinic
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Erica D Wittwer, MD, PhD Mayo Clinic
PRS Account Mayo Clinic
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP