MicroRNAs in Acute Kidney Injury | NCT03089242

Studies
MicroRNAs in Acute Kidney Injury

NCT03089242

Sponsor

Heinrich-Heine University, Duesseldorf

Status

Completed

Last Update Posted

May 7, 2020Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Kidney Injury in Cardiac Surgery - Expression of microRNAs

Interventions

observation of microRNA expression

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Jun 30, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Mar 20, 2017

First Submission Date that Met QC Criteria

Mar 20, 2017

First Posted Date

Mar 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2020

Last Update Posted Date

May 7, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Klinik für Anästhesiologie, PD Dr. Timo Brandenburger, Heinrich-Heine University, DuesseldorfPrincipal Investigator

Lead Sponsor

Heinrich-Heine University, DuesseldorfOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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?

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

150Actual

Name	Type	Description	Arm Group Labels	Other Names
observation of microRNA expression	Other	no intervention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Cardiac surgery patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Timo Brandenburger, M.D.	Klinik für Anästhesiologie, Heinrich-Heine-Universität Düsseldorf	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinik für Anästhesiologie		Düsseldorf		40225	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided