Ketamine and Kidney Injury in Cardiac Surgery

NCT ID: NCT05268562

Last Updated: 2025-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-02

Study Completion Date

2026-06-30

Brief Summary

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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

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Conditions

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Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Anesthesia induction with Ketamine

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

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

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

Anesthesia induction with Propofol

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

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

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

Interventions

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Ketamine

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

Intervention Type DRUG

Propofol

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Erica D. Wittwer, M.D., Ph.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erica D Wittwer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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21-004327

Identifier Type: -

Identifier Source: org_study_id

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