The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction
Primary Purpose
Cognitive Disorders, Delirium, Acute Kidney Injury
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Propofol
Sponsored by
About this trial
This is an interventional prevention trial for Cognitive Disorders
Eligibility Criteria
Scheduled to undergo cardiac surgery.
Inclusion criteria:
- age greater than or equal to 75 years presenting for cardiac surgery at the Mayo Clinic in Rochester, Minnesota;
- schedule to undergo complex cardiac surgery. Complex cardiac surgery will be defined as surgery involving more than one heart valve, redo-sternotomy procedures, or combined valvular and CABG procedures.
Exclusion criteria will include:
- left or right ventricular assist device implantation or explantation,
- procedures not requiring cardiopulmonary bypass,
- active infection or sepsis, severe hepatic disease or ascites,
- pre-operative renal dysfunction including a baseline creatinine equal to or greater than 1.5 mg/dL or requiring dialysis,
- immunosuppressive medication use (including steroid use),
- immunodeficiency syndrome,
- known neurologic or psychiatric disorder, or
- use of drugs for psychosis.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
ketamine
Propofol
Arm Description
Ketamine induction
Propofol induction
Outcomes
Primary Outcome Measures
Number of Patients With Postoperative Cognitive Dysfunction
Pre and postoperative cognitive studies will be performed to assess change in cognitive function.
Postoperative cognitive dysfunction (POCD) was defined a-priori as a decline of decline of >1 standard deviation (i.e. z-score decline of > 1) on at least 2 neurocognitive tests. The neurocognitive tests utilized include Trail making Test A, Trail making Test B, Hopkins Verbal Learning Test-Revised Learning trials, Hopkins Verbal Learning Test-Revised Delayed Recall, Digit Span, Controlled Oral Word Association Test, Stroop color/word test, and the Mini Mental Status Examination.
Secondary Outcome Measures
Number of Patients With Acute Kidney Injury
AKI was defined by Kidney Disease Improving Global Outcomes (KDIGO) criteria including an increase in serum creatinine ≥0.3 mg/dL within 48 hours, an increase in serum creatinine to ≥1.5 times baseline within 7 days, and urine output < 0.5 mL/kg/hr for 6 hours.
Number of Patients Who Develop Postoperative Delirium
Delirium was defined as a positive CAM (Confusion assessment method) score. CAM score was recorded every 12 hours postoperatively as per routine. The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4. The score is either positive or negative. Positive means the patient has delirium and negative indicates the patient is not delirious.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02554253
Brief Title
The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction
Official Title
The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction in Patients 75 Years of Age or Older and Undergoing Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Ketamine is a commonly used anesthetic medication which is used for induction of anesthesia as well as as an analgesic. It has been shown to have anti-inflammatory properties which may decrease post-operative complications following cardiac surgery with cardiopulmonary bypass that are thought to associated with inflammation. Some studies have shown that ketamine does decrease these complications when compared with anesthetics that are not commonly used in our cardiac anesthesiology practice. Propofol is another commonly used anesthetic medication which is used for induction of anesthesia. Ketamine has not been compared with propofol for potential to reduce post-operative complications associated with the inflammatory process. This study aims to see if ketamine will reduce the incidence of cognitive dysfunction, delirium, and renal dysfunction in comparison with propofol. In addition, the hemodynamic impact of ketamine compared propofol will be investigated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Disorders, Delirium, Acute Kidney Injury
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ketamine
Arm Type
Active Comparator
Arm Description
Ketamine induction
Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
Propofol induction
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Ketalar
Intervention Description
Ketamine used for induction
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Diprivan, Propoven
Intervention Description
Propofol for induction
Primary Outcome Measure Information:
Title
Number of Patients With Postoperative Cognitive Dysfunction
Description
Pre and postoperative cognitive studies will be performed to assess change in cognitive function.
Postoperative cognitive dysfunction (POCD) was defined a-priori as a decline of decline of >1 standard deviation (i.e. z-score decline of > 1) on at least 2 neurocognitive tests. The neurocognitive tests utilized include Trail making Test A, Trail making Test B, Hopkins Verbal Learning Test-Revised Learning trials, Hopkins Verbal Learning Test-Revised Delayed Recall, Digit Span, Controlled Oral Word Association Test, Stroop color/word test, and the Mini Mental Status Examination.
Time Frame
Baseline (preoperative cognitive tests) to hospital discharge or 10 days postoperatively whichever came first.
Secondary Outcome Measure Information:
Title
Number of Patients With Acute Kidney Injury
Description
AKI was defined by Kidney Disease Improving Global Outcomes (KDIGO) criteria including an increase in serum creatinine ≥0.3 mg/dL within 48 hours, an increase in serum creatinine to ≥1.5 times baseline within 7 days, and urine output < 0.5 mL/kg/hr for 6 hours.
Time Frame
Baseline (preoperative cognitive tests) to hospital discharge or 10 days postoperatively whichever came first.
Title
Number of Patients Who Develop Postoperative Delirium
Description
Delirium was defined as a positive CAM (Confusion assessment method) score. CAM score was recorded every 12 hours postoperatively as per routine. The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4. The score is either positive or negative. Positive means the patient has delirium and negative indicates the patient is not delirious.
Time Frame
Baseline (preoperative cognitive tests) to hospital discharge or 10 days postoperatively whichever came first.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Scheduled to undergo cardiac surgery.
Inclusion criteria:
age greater than or equal to 75 years presenting for cardiac surgery at the Mayo Clinic in Rochester, Minnesota;
schedule to undergo complex cardiac surgery. Complex cardiac surgery will be defined as surgery involving more than one heart valve, redo-sternotomy procedures, or combined valvular and CABG procedures.
Exclusion criteria will include:
left or right ventricular assist device implantation or explantation,
procedures not requiring cardiopulmonary bypass,
active infection or sepsis, severe hepatic disease or ascites,
pre-operative renal dysfunction including a baseline creatinine equal to or greater than 1.5 mg/dL or requiring dialysis,
immunosuppressive medication use (including steroid use),
immunodeficiency syndrome,
known neurologic or psychiatric disorder, or
use of drugs for psychosis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erica Wittwer, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction
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