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NCT Number: NCT01612117

Urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) 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.

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Key information

Conditions

Renal Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiology

Fribourg, Canton of Fribourg, 1708, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All except patients with exclusion criteria

Exclusion criteria

  • dialysis-dependent chronic kidney disease
  • lack of written consent

Treatment and study plan

Primary outcomes

  1. 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

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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

    Time frame: 4-6 hours after PCP

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Sponsors and collaborators

Lead sponsor

University of Freiburg

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 5, 2012
Registry last updated
May 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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