Back to resultsPrevention and Early Detection and Intervention of Post-Coronary Artery Bypass Grafting Surgery (CABG) Acute Kidney Injury (AKI)
Primary Purpose
Acute Renal Injury, Preventive Measures
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of Care plus Nephrology Care
Sponsored by
About this trial
This is an interventional prevention trial for Acute Renal Injury
Eligibility Criteria
Inclusion Criteria:
- Adult patients (Age >18 years)
- Elective CABG at Mayo Clinic Rochester and Shanghai Zhongshan Hospital from 7/1/2016 to 6/30/2017
Exclusion Criteria:
- Non-elective CABG
- Renal failure on dialysis
- Renal transplantation
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard of Care
Standard of Care plus Nephrology Care
Arm Description
If participants are randomized into the non-intervention group, the participants' information during the study period will be collected. Participants will be managed by a care provider as per the standard of care. Participants may receive nephrology consultation as indicated clinically.
If participants are randomized into the intervention group, participants' information will be checked by the study investigators daily for 7 days (2 days pre-op and 5 days post-op). When appropriate, investigators may give suggestions to minimize the participants' risk(s) for AKI. Participant's primary care providers may take the suggestions into consideration. Participants' primary care providers are not obligated to carry out the suggestions that are given.
Outcomes
Primary Outcome Measures
Perfusion pressures (mean arterial pressure) ≥ 65-70 mmHg
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02838667
Brief Title
Prevention and Early Detection and Intervention of Post-Coronary Artery Bypass Grafting Surgery (CABG) Acute Kidney Injury (AKI)
Official Title
Prevention and Early Detection and Intervention of Post-Coronary Artery Bypass Grafting Surgery (CABG) Acute Kidney Injury (AKI)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
June 10, 2019 (Actual)
Study Completion Date
June 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Nephrology participation in care of patients undergoing CABG could reduce AKI through correction of modifiable risk factors and early detection and intervention of post-op AKI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Renal Injury, Preventive Measures
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
If participants are randomized into the non-intervention group, the participants' information during the study period will be collected. Participants will be managed by a care provider as per the standard of care. Participants may receive nephrology consultation as indicated clinically.
Arm Title
Standard of Care plus Nephrology Care
Arm Type
Experimental
Arm Description
If participants are randomized into the intervention group, participants' information will be checked by the study investigators daily for 7 days (2 days pre-op and 5 days post-op). When appropriate, investigators may give suggestions to minimize the participants' risk(s) for AKI. Participant's primary care providers may take the suggestions into consideration. Participants' primary care providers are not obligated to carry out the suggestions that are given.
Intervention Type
Procedure
Intervention Name(s)
Standard of Care plus Nephrology Care
Primary Outcome Measure Information:
Title
Perfusion pressures (mean arterial pressure) ≥ 65-70 mmHg
Time Frame
baseline to 5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients (Age >18 years)
Elective CABG at Mayo Clinic Rochester and Shanghai Zhongshan Hospital from 7/1/2016 to 6/30/2017
Exclusion Criteria:
Non-elective CABG
Renal failure on dialysis
Renal transplantation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qi Qian, MD
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
Prevention and Early Detection and Intervention of Post-Coronary Artery Bypass Grafting Surgery (CABG) Acute Kidney Injury (AKI)
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