Prevention and Early Detection and Intervention of Post-Coronary Artery Bypass Grafting Surgery (CABG) Acute Kidney Injury (AKI)
1 other identifier
interventional
2,300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 18, 2016
CompletedFirst Posted
Study publicly available on registry
July 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2019
CompletedOctober 10, 2019
October 1, 2019
2.9 years
July 18, 2016
October 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Perfusion pressures (mean arterial pressure) ≥ 65-70 mmHg
baseline to 5 days
Study Arms (2)
Standard of Care
NO INTERVENTIONIf 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.
Standard of Care plus Nephrology Care
EXPERIMENTALIf 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.
Interventions
Eligibility Criteria
You may qualify if:
- Adult patients (Age \>18 years)
- Elective CABG at Mayo Clinic Rochester and Shanghai Zhongshan Hospital from 7/1/2016 to 6/30/2017
You may not qualify if:
- Non-elective CABG
- Renal failure on dialysis
- Renal transplantation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qi Qian, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
July 18, 2016
First Posted
July 20, 2016
Study Start
July 1, 2016
Primary Completion
June 10, 2019
Study Completion
June 10, 2019
Last Updated
October 10, 2019
Record last verified: 2019-10