NCT02580292

Brief Summary

To determine if ultrasound measurement of renal and carotid arterial resistive indices are associated with post-cardiac surgery acute kidney injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2015

Longer than P75 for all trials

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

October 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2024

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

8.6 years

First QC Date

October 17, 2015

Last Update Submit

November 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Acute kidney injury - Lassnigg grade-minimal

    Based on change in creatinine

    2nd postoperative day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing cardiac surgery

You may qualify if:

  • adult patients \>= 18 years
  • undergoing cardiac surgery with cardiopulmonary bypass and transesophageal echocardiography (TEE) probe placement

You may not qualify if:

  • chronic kidney diseases (estimated GFR \< 60 ml/min/1.73m2)
  • prior carotid endarterectomy
  • known carotid artery stenosis of 50% or greater
  • dissection or aneurysm involving renal or carotid arteries
  • scheduled aortic or aortic valve surgery
  • heart transplant
  • intraaortic balloon pump, ventricular assist device, or exctracorporeal membrane oxygenation support.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Center - University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

  • Milo Engoren

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 17, 2015

First Posted

October 20, 2015

Study Start

October 1, 2015

Primary Completion

April 25, 2024

Study Completion

April 25, 2024

Last Updated

November 12, 2024

Record last verified: 2024-11

Locations