Kidney Injury in Cardiac Surgery - Expression of microRNAsMIRAKINCT03089242
MicroRNAs in Acute Kidney Injury
An observational study of Kidney Injury in Cardiac Surgery - Expression of microRNAs, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial 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? Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Kidney Injury in Cardiac Surgery - Expression of microRNAs
- What is being tested?
- observation of microRNA expression
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Study population: Cardiac surgery patients
Who may be able to join
- cardiac surgery
- pregnancy
- Kidney transplantation in history
- GFR < 30 ml/min (glomerular filtration rate)
- ECLS therapy (extracorporal life support)
Who cannot join
- preexisting chronic kidney injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read the 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.
- Being tested
- observation of microRNA expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observation of microRNA expressionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
acute kidney injury
AKI Stadium II or III following cardiac surgery.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start1 Sep 2017
- Primary completion30 Jun 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Injury in Cardiac Surgery - Expression of microRNAsStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klinik für Anästhesiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Timo Brandenburger, M.D., Principal investigator, Klinik für Anästhesiologie, Heinrich-Heine-Universität Düsseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089242
- Sponsor's protocol ID
- 2017024132
- Acronym
- MIRAKI
- Status last verified
- May 2020
- First submitted
- 20 Mar 2017
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MicroRNAs in Acute Kidney Injury (MIRAKI) - a Pilotstudy -
- ClinicalTrials.gov ID
- NCT03089242
- Acronym / sponsor ID
- MIRAKI / 2017024132
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 24 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Cardiac surgery patients
Key inclusion criteria (5 listed)
- cardiac surgery
- pregnancy
- Kidney transplantation in history
- GFR < 30 ml/min (glomerular filtration rate)
- ECLS therapy (extracorporal life support)
Key exclusion criteria (1 listed)
- preexisting chronic kidney injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observation of microRNA expressionno intervention | Other | – |
Primary outcome
acute kidney injury
Time frame: 1 year
AKI Stadium II or III following cardiac surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timo Brandenburger, M.D. principal investigator
Klinik für Anästhesiologie, Heinrich-Heine-Universität Düsseldorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Injury in Cardiac Surgery - Expression of microRNAs, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute kidney injury (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2020.