- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02978378
Renal Biomarkers to Predict Recovery Following Venoarterial Extracorporeal Membrane Oxygenation
March 29, 2018 updated by: Anthony Bonavia, Milton S. Hershey Medical Center
The investigators objective is to assess the utility of renal biomarkers in predicting renal recovery following institution of Venoarterial Extracorporeal Membrane Oxygenation (VA-ECMO).
Tissue biomarkers of renal injury may provide a real-time indication of renal function and the likelihood of renal recovery in patients having cardiogenic shock and requiring VA-ECMO.
In these patients, traditional markers of kidney function (urine output and serum Creatinine level) do not accurately represent renal function.
Study Overview
Study Type
Observational
Enrollment (Actual)
2
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
-
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Milton S. Hershey Medical Center
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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 to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with cardiogenic shock and acute kidney injury requiring continuous renal replacement therapy
Description
Inclusion Criteria:
- age more than 18 years
- refractory or advanced cardiogenic shock prior to institution of VA-ECMO
Exclusion Criteria:
- History of chronic kidney disease prior to cardiogenic shock, as defined by estimated glomerular filtration rate (GFR) less than 60 mL per min
- Cognitive impairment
- Pregnant women
- patient or surrogate is not fluent in English
- Long-term immunosuppression
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
renal biomarker levels
Time Frame: through VA-ECMO decannulation, an average of 3 weeks
|
through VA-ECMO decannulation, an average of 3 weeks
|
|
need for continuous renal replacement therapy at hospital discharge (Yes/No)
Time Frame: measured at hospital discharge, an average of 2-3 months following initial hospital admission
|
The need for continuous renal replacement therapy at hospital discharge will be assessed using hospital medical records
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measured at hospital discharge, an average of 2-3 months following initial hospital admission
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anthony Bonavia, Milton S. Hershey Medical Center
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 (Actual)
May 1, 2017
Primary Completion (Actual)
March 23, 2018
Study Completion (Actual)
March 23, 2018
Study Registration Dates
First Submitted
November 17, 2016
First Submitted That Met QC Criteria
November 29, 2016
First Posted (Estimate)
November 30, 2016
Study Record Updates
Last Update Posted (Actual)
April 2, 2018
Last Update Submitted That Met QC Criteria
March 29, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00006088
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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