- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03089242
MicroRNAs in Acute Kidney Injury (MIRAKI)
May 6, 2020 updated by: Klinik für Anästhesiologie, Heinrich-Heine University, Duesseldorf
MicroRNAs in Acute Kidney Injury (MIRAKI) - a Pilotstudy -
Profiling of microRNAs and long noncoding RNAs (lncRNAs) in patients undergoing cardiac surgery.
Analysis: Prediction of acute kidney injury by plasma expression profile of microRNAs?
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
In this pilot study we will include 150 patients undergoing cardiac surgery in a German university hospital.
We will profile microRNA expression in plasma and urine before and at several timepoints after surgery.
We will use a preselected panel of microRNAs and lncRNAs for analysis.
Goal is to identify microRNAs/lncRNAs that are able to predict the occurence of AKI in these patients.
Study Type
Observational
Enrollment (Actual)
150
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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Düsseldorf, Germany, 40225
- Klinik für Anästhesiologie
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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 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Cardiac surgery patients
Description
Inclusion Criteria:
- cardiac surgery
Exclusion Criteria:
- preexisting chronic kidney injury
- inclusion in another study
- pregnancy
- Kidney transplantation in history
- GFR < 30 ml/min (glomerular filtration rate)
- ECLS therapy (extracorporal life 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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
acute kidney injury
Time Frame: 1 year
|
AKI Stadium II or III following cardiac surgery.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Timo Brandenburger, M.D., Klinik für Anästhesiologie, Heinrich-Heine-Universität Düsseldorf
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)
September 1, 2017
Primary Completion (Actual)
June 30, 2018
Study Completion (Actual)
December 31, 2018
Study Registration Dates
First Submitted
March 20, 2017
First Submitted That Met QC Criteria
March 20, 2017
First Posted (Actual)
March 24, 2017
Study Record Updates
Last Update Posted (Actual)
May 7, 2020
Last Update Submitted That Met QC Criteria
May 6, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017024132
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.