Renal FailureNCT01612117
Urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) in Invasive Cardiology
An observational study of Renal Failure, run by University of Freiburg at 1 site in Switzerland.
Trial summary
Diagnosis of acute kidney injury (AKI) relies on a late marker, namely serum creatinine (SCr). New biomarkers are considered for early and sensitive detection of CIN. In particular, uNGAL has been used for early detection of AKI in the emergency department, after cardiopulmonary bypass or following CM administration. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Renal Failure
- How many people
- 244 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2011to Feb 2012
- 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
- No healthy volunteers
- Adult, Older adult
Study population: all consecutive patients
Who may be able to join
- All except patients with exclusion criteria
Who cannot join
- dialysis-dependent chronic kidney disease
- lack of written consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Cardiology
Fribourg, Canton of Fribourg, 1708
About this study
Official title: Is Urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) the "Renal Troponin" in Invasive Cardiology?
Diagnosis of acute kidney injury (AKI) relies on a late marker, namely serum creatinine (SCr). New biomarkers are considered for early and sensitive detection of CIN. In particular, uNGAL has been used for early detection of AKI in the emergency department, after cardiopulmonary bypass or following CM administration.
This study will be conducted to assess the possible value of urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) as an early detector of contrast-induced nephropathy (CIN) in a large sized cohort of patients undergoing percutaneous coronary procedures (PCP) and whether or not uNGAL correlates with the volume of contrast medium (CM) used.
Read the detailed description
Methods. We will enroll all consecutive patients undergoing PCP with iomeprolum during a 3-month period at our institution. CIN will be defined as a ≥25% increase in SCr from baseline when measured 2-4 days after PCP. uNGAL will be measured at its peak with the Abbott ARCHITECT assay.
- Conditions
- Renal Failure
- Keywords
- renal failure, cardiology, contrast-induced nephropathy
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| consecutive, PCP patients | All patients requiring percutaneous coronary procedures, such as coronary angiography or intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
to assess the value of uNGAL measurement 4 to 6 hours after PCP as a possible early detector of CIN
cf title
Measured: 4-6 hours after PCP
Secondary outcomes (1)
to study the relationship between the volume of contrast medium used for PCP and the uNGAL levels measured 4 to 6 hours thereafter
cf. title
Measured: 4-6 hours after PCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startNov 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- 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
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Freiburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stéphane Cook, Prof, University of Freiburg
- Investigators
- Stephane Cook, MD, Study chair, University Fribourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612117
- Sponsor's protocol ID
- 013-REP-CER-FR
- Status last verified
- May 2014
- First submitted
- 30 May 2012
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Perrin T, Descombes E, Magnin JL, Gachet M, Hemett OM, Hayoz D, Stolt V, Baeriswyl G, Stauffer JC, Goy JJ, Togni M, Cook S. Urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) and contrast-induced acute kidney injury after coronary angiogram. Swiss Med Wkly. 2013 Aug 27;143:w13853. doi: 10.4414/smw.2013.13853. eCollection 2013.
PubMed 23986375
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) the "Renal Troponin" in Invasive Cardiology?
- ClinicalTrials.gov ID
- NCT01612117
- Acronym / sponsor ID
- 013-REP-CER-FR
- Conditions
- Renal Failure
- Keywords
- renal failure, cardiology, contrast-induced nephropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- University of FreiburgUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 5 Jun 2012 (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.
Diagnosis of acute kidney injury (AKI) relies on a late marker, namely serum creatinine (SCr). New biomarkers are considered for early and sensitive detection of CIN. In particular, uNGAL has been used for early detection of AKI in the emergency department, after cardiopulmonary bypass or following CM administration.
This study will be conducted to assess the possible value of urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) as an early detector of contrast-induced nephropathy (CIN) in a large sized cohort of patients undergoing percutaneous coronary procedures (PCP) and whether or not uNGAL correlates with the volume of contrast medium (CM) used.
Detailed description
Methods. We will enroll all consecutive patients undergoing PCP with iomeprolum during a 3-month period at our institution. CIN will be defined as a ≥25% increase in SCr from baseline when measured 2-4 days after PCP. uNGAL will be measured at its peak with the Abbott ARCHITECT assay.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| consecutive, PCP patients | – | –All patients requiring percutaneous coronary procedures, such as coronary angiography or intervention |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all consecutive patients
Key inclusion criteria (1 listed)
- All except patients with exclusion criteria
Key exclusion criteria (2 listed)
- dialysis-dependent chronic kidney disease
- lack of written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
to assess the value of uNGAL measurement 4 to 6 hours after PCP as a possible early detector of CIN
Time frame: 4-6 hours after PCP
cf title
1 secondary outcome
to study the relationship between the volume of contrast medium used for PCP and the uNGAL levels measured 4 to 6 hours thereafter
Time frame: 4-6 hours after PCP
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 28 May 2014.
- Results publication: PubMed 23986375Perrin T, Descombes E, Magnin JL, Gachet M, Hemett OM, Hayoz D, Stolt V, Baeriswyl G, Stauffer JC, Goy JJ, Togni M, Cook S. Urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) and contrast-induced acute kidney injury after coronary angiogram. Swiss Med Wkly. 2013 Aug 27;143:w13853. doi: 10.4414/smw.2013.13853. eCollection 2013.
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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.
Stephane Cook, MD study chair
University Fribourg
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 Renal Failure, run by University of Freiburg at 1 site in Switzerland.
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 1 inclusion and 2 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 28 May 2014. 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 Switzerland. 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?
to assess the value of uNGAL measurement 4 to 6 hours after PCP as a possible early detector of CIN (time frame: 4-6 hours after PCP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01612117, which also lists 1 linked publication.
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 28 May 2014.