Cardiac SurgeryPhase 4NCT05268562

Ketamine and Kidney Injury in Cardiac Surgery

A Phase 4 study testing Ketamine and Propofol in people with Cardiac Surgery, run by Mayo Clinic at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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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. Read more about this study

Who is it for?: Ages 70 years and older
Conditions the study is for: Cardiac Surgery
What is being tested?: Ketamine and Propofol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 siteUnited States
Study dates: 2 Mar 2022to 1 Jun 2027
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 70 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

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

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
Being tested: Ketamine, Propofol
Keywords: Cardiopulmonary bypass

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KetamineDrug
1-2 mg/kg induction with additional medication administered as needed to achieve intubating conditions
PropofolDrug
0.5-1 mg/kg induction with additional medication administered as needed to achieve intubating conditions

Study groups in NCT05268562
Study group	Role	What they receive
Anesthesia induction with Ketamine	Active comparator	Subjects will receive Ketamine to begin anesthesia for their cardiac surgery. Receives: Drug: Ketamine
Anesthesia induction with Propofol	Active comparator	Subjects will receive Propofol to begin anesthesia for their cardiac surgery. Receives: Drug: Propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Acute Kidney Injury
The incidence of acute kidney injury in patients following cardiac surgery
Measured: Immediately postop up to 10 days postoperatively

Secondary outcomes (1)

Number of Participants Receiving Vasopressors
Compare vasopressor use between groups at and following induction as a surrogate for hemodynamic differences
Measured: Immediately post induction up to 30 minute following induction

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Mar 20221 Jun 2027

First posted7 Mar 2022
Study start2 Mar 2022
Primary completion5 Sep 2025
Study completion1 Jun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05268562
Sponsor's protocol ID: 21-004327
Status last verified: Aug 2026
First submitted: 8 Feb 2022
Last updated: 20 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cardiac Surgery trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Ketamine Versus Propofol for Anesthetic Induction on Acute Kidney Injury and Renal Biomarkers in Cardiac Surgery
ClinicalTrials.gov ID: NCT05268562
Acronym / sponsor ID: 21-004327
Conditions: Cardiac Surgery
Keywords: Cardiopulmonary bypass
Phase: Phase 4
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 200 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 2 Mar 2022 (actual)
Primary completion: 5 Sep 2025 (actual)
Study completion: 1 Jun 2027 (estimated)
First posted: 7 Mar 2022 (actual)
Results: Posted 20 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Anesthesia induction with Ketamine	Active comparator	Drug: KetamineSubjects will receive Ketamine to begin anesthesia for their cardiac surgery.
Anesthesia induction with Propofol	Active comparator	Drug: PropofolSubjects will receive Propofol to begin anesthesia for their cardiac surgery.

Who may qualify

Ages: 70 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (2 listed)

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).

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ketamine1-2 mg/kg induction with additional medication administered as needed to achieve intubating conditions	Drug	Anesthesia induction with Ketamine
Propofol0.5-1 mg/kg induction with additional medication administered as needed to achieve intubating conditions	Drug	Anesthesia induction with Propofol

Primary outcome

Number of Participants With Acute Kidney Injury
Time frame: Immediately postop up to 10 days postoperatively
The incidence of acute kidney injury in patients following cardiac surgery

1 secondary outcome

Number of Participants Receiving Vasopressors
Time frame: Immediately post induction up to 30 minute following induction

Results and safety

Results posted to the registry on 20 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Anesthesia Induction With Ketamine	100	89
Anesthesia Induction With Propofol	100	97

Primary outcome: Number of Participants With Acute Kidney Injury

Time frame: Immediately postop up to 10 days postoperatively. Count of participants. Unit: Participants

Measure	Anesthesia Induction With Ketamine n = 89	Anesthesia Induction With Propofol n = 97
Value	53	47

Anesthesia Induction With Ketamine vs Anesthesia Induction With Propofol: p = 0.13, Chi-squared

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up until one week from surgery. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Anesthesia Induction With Ketamine	0 of 89 (0%)	0 of 89 (0%)	0 of 89
Anesthesia Induction With Propofol	0 of 97 (0%)	0 of 97 (0%)	3 of 97

Limitations and caveats (from the sponsor): Caveats: Initially intended to assess impact of renal biomarkers on ability to predict AKI however due to changes in cost over time as well as addition of some biomarkers as standard of care at a different time point, these were unable to be assessed. Limitations: The intervention, induction with one of two agents, could not be blinded from the anesthesiologists. This could allow for bias due to beliefs about impact of either medication to impact the amount given or additional therapies used.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Mayo Clinic Clinical TrialsLink provided by the sponsor.

Related trials for Cardiac Surgery

RecruitingPhase 2/3
Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
Pain, Postoperative
Active, not recruiting
Comparing Different Regional Blocks for Analgesia After Off-pump Cardiac Surgery
Analgesia
Recruiting
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
Aortic Regurgitation, Aortic Valve Insufficiency
Not yet recruiting
Boyle-Davis Mouth Gag Timing in Pediatric Tonsil Surgery
Tonsillectomy and Adenotonsillectomy in Children
Active, not recruiting
Low Tidal Volume Ventilation With Hyperoxia Avoidance During Cardiopulmonary Bypass (The FOCUS Trial)
Cardiac Surgery

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Erica D Wittwer, MD, PhD principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ketamine and Propofol in people with Cardiac Surgery, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Acute Kidney Injury (time frame: Immediately postop up to 10 days postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05268562.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.