Urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL... | NCT01612117

Studies
Urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) in Invasive Cardiology

NCT01612117

Sponsor

University of Freiburg

Status

Completed

Last Update Posted

May 28, 2014Estimated

Enrollment

244Actual

Phase

Not provided

Conditions

Renal Failure

Interventions

Not provided

Countries

Switzerland

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 2014

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

Nov 2011

Primary Completion Date

Feb 2012Actual

Completion Date

Feb 2012Actual

First Submitted Date

May 30, 2012

First Submission Date that Met QC Criteria

Jun 4, 2012

First Posted Date

Jun 5, 2012Estimated

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 27, 2014

Last Update Posted Date

May 28, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

244Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
consecutive, PCP patients		All patients requiring percutaneous coronary procedures, such as coronary angiography or intervention

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to assess the value of uNGAL measurement 4 to 6 hours after PCP as a possible early detector of CIN	cf title	4-6 hours after PCP

Secondary Outcomes

Measure	Description	Time Frame
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	4-6 hours after PCP

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All except patients with exclusion criteria

Exclusion Criteria:

dialysis-dependent chronic kidney disease
lack of written consent

Accepts Healthy Volunteers

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

all consecutive patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephane Cook, MD	University Fribourg	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Cardiology		Fribourg	Canton of Fribourg	1708	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23986375	Result	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.

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications