MicroRNAs in Acute Kidney Injury (MIRAKI)

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
• Conditions: Kidney Injury in Cardiac Surgery - Expression of microRNAs
• Intervention / Treatment: Other: observation of microRNA expression

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

Study Locations

• Germany
  • Düsseldorf, Germany, 40225
    • Klinik für Anästhesiologie

Participation Criteria

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
acute kidney injury	AKI Stadium II or III following cardiac surgery.	1 year

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf
• Investigators: Principal Investigator: Timo Brandenburger, M.D., Klinik für Anästhesiologie, Heinrich-Heine-Universität Düsseldorf

Study record dates

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: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Wounds and Injuries; Acute Kidney Injury
• 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