NCT02838667

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2019

Completed
Last Updated

October 10, 2019

Status Verified

October 1, 2019

Enrollment Period

2.9 years

First QC Date

July 18, 2016

Last Update Submit

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 INTERVENTION

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.

Standard of Care plus Nephrology Care

EXPERIMENTAL

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

Interventions

Standard of Care plus Nephrology Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Qi Qian, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

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

Locations