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

Renal Failure Clinical Trial

Official title:

Is Urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) the "Renal Troponin" in Invasive Cardiology?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01612117
• Other study ID #: 013-REP-CER-FR
• Status: Completed
• Phase: N/A
• First received: May 30, 2012
• Last updated: May 27, 2014
• Start date: November 2011
• Est. completion date: February 2012

Study information

• Verified date: May 2014
• Source: University of Freiburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• All except patients with exclusion criteria

Exclusion Criteria:

• dialysis-dependent chronic kidney disease

• lack of written consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Renal Failure
• Renal Insufficiency

Locations

Country	Name	City	State
Switzerland	Department of Cardiology	Freiburg	Fribourg

Sponsors (1)

Lead Sponsor	Collaborator
University of Freiburg

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No