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Prevention and Early Detection and Intervention of Post-Coronary Artery Bypass Grafting Surgery (CABG) Acute Kidney Injury (AKI)

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ClinicalTrials.gov Identifier: NCT02838667
Recruitment Status : Completed
First Posted : July 20, 2016
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Qi Qian, M.D., Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Acute Renal Injury Preventive Measures Procedure: Standard of Care plus Nephrology Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention and Early Detection and Intervention of Post-Coronary Artery Bypass Grafting Surgery (CABG) Acute Kidney Injury (AKI)
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : June 10, 2019
Actual Study Completion Date : June 10, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard of Care
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.
Experimental: Standard of Care plus Nephrology Care
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.
Procedure: Standard of Care plus Nephrology Care



Primary Outcome Measures :
  1. Perfusion pressures (mean arterial pressure) ≥ 65-70 mmHg [ Time Frame: baseline to 5 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02838667


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Qi Qian, MD Mayo Clinic

Additional Information:
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Responsible Party: Qi Qian, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02838667     History of Changes
Other Study ID Numbers: 16-003845
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases