Acute Kidney InjuryNCT02352506
Serum MIF in Acute Kidney Injury
An observational study of Acute Kidney Injury, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Acute kidney injury (AKI) is a common complication in critical care patients. Currently no parameters are available for early prognosis of AKI. Macrophage migration inhibitory factor (MIF) has been associated with AKI in clinical studies. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Blood draw for measurement of MIF
- How many people
- 500 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2015to Jan 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critical care patients
Who may be able to join
None listed.
Who cannot join
- Age < 18 years and > 80 years
- Patients with chronic dialysis
- Patients with continuous hemodialysis, hemofiltration or hemodiafiltration within 4 weeks prior to the study
- Patients with an expected length of ICU stay shorter than 3 days
- Patients with a low probability of surviving the first 2 days after ICU admission
- Pregnancy and nursing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Macrophage Migration Inhibitory Factor in the Serum of Critically Ill Patients as an Early Marker for Acute Kidney Injury
Acute kidney injury (AKI) is a common complication in critical care patients. Currently no parameters are available for early prognosis of AKI. Macrophage migration inhibitory factor (MIF) has been associated with AKI in clinical studies. The aim of this study is to evaluate the time course of MIF concentrations in patients with AKI.
- Conditions
- Acute Kidney Injury
- Being tested
- Blood draw for measurement of MIF
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood draw for measurement of MIFOther
Observational study, no intervention
| Study group | Role | What they receive |
|---|---|---|
| AKI | Patients developing AKI during the ICU stay Receives: Other: Blood draw for measurement of MIF | |
| No AKI | Matched controls not developing AKI during the ICU stay Receives: Other: Blood draw for measurement of MIF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macrophage migration inhibitory factor
Measured: Up to 14 days
Secondary outcomes (1)
Serum creatinine
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionNov 2019
- Study completionJan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David M Baron, MD, PhD, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352506
- Sponsor's protocol ID
- 1680/2014
- Status last verified
- Mar 2023
- First submitted
- 28 Jan 2015
- Last updated
- 15 Mar 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macrophage Migration Inhibitory Factor in the Serum of Critically Ill Patients as an Early Marker for Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT02352506
- Acronym / sponsor ID
- 1680/2014
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Jan 2023 (actual)
- First posted
- 2 Feb 2015 (estimated)
- 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.
Acute kidney injury (AKI) is a common complication in critical care patients. Currently no parameters are available for early prognosis of AKI. Macrophage migration inhibitory factor (MIF) has been associated with AKI in clinical studies. The aim of this study is to evaluate the time course of MIF concentrations in patients with AKI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKI | – | Other: Blood draw for measurement of MIFPatients developing AKI during the ICU stay |
| No AKI | – | Other: Blood draw for measurement of MIFMatched controls not developing AKI during the ICU stay |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critical care patients
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Age < 18 years and > 80 years
- Patients with chronic dialysis
- Patients with continuous hemodialysis, hemofiltration or hemodiafiltration within 4 weeks prior to the study
- Patients with an expected length of ICU stay shorter than 3 days
- Patients with a low probability of surviving the first 2 days after ICU admission
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 |
|---|---|---|
| Blood draw for measurement of MIFObservational study, no intervention | Other | AKI, No AKI |
Primary outcome
Macrophage migration inhibitory factor
Time frame: Up to 14 days
1 secondary outcome
Serum creatinine
Time frame: Up to 14 days
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 15 Mar 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Kidney Injury, run by Medical University of Vienna at 1 site in Austria.
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 0 inclusion and 6 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 15 Mar 2023. 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 Austria. 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?
Macrophage migration inhibitory factor (time frame: Up to 14 days). 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 15 Mar 2023.