- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02580292
Diagnostic Accuracy of Doppler Resistive Indices for Early Diagnosis of Acute Kidney Injury .
November 9, 2024 updated by: Milo Engoren, University of Michigan
Diagnostic Accuracy of Renal, Carotid, and Aortic Doppler Resistive Indices for Early Diagnosis of Acute Kidney Injury Following Cardiopulmonary Bypass Surgery.
To determine if ultrasound measurement of renal and carotid arterial resistive indices are associated with post-cardiac surgery acute kidney injury.
Study Overview
Status
Completed
Conditions
Detailed Description
To determine if ultrasound measurement of renal and carotid arterial resistive indices are associated with post-cardiac surgery acute kidney injury.
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- Cardiovascular Center - University of Michigan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adult patients undergoing cardiac surgery
Description
Inclusion Criteria:
- adult patients >= 18 years
- undergoing cardiac surgery with cardiopulmonary bypass and transesophageal echocardiography (TEE) probe placement
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acute kidney injury - Lassnigg grade-minimal
Time Frame: 2nd postoperative day
|
Based on change in creatinine
|
2nd postoperative day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Milo Engoren, University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Actual)
April 25, 2024
Study Completion (Actual)
April 25, 2024
Study Registration Dates
First Submitted
October 17, 2015
First Submitted That Met QC Criteria
October 17, 2015
First Posted (Estimated)
October 20, 2015
Study Record Updates
Last Update Posted (Actual)
November 12, 2024
Last Update Submitted That Met QC Criteria
November 9, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1 (Mobile Health and Wellness Program)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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