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Neutrophil Gelatinase-associated Lipocalin (NGAL) and Contrast Media Induced Nephropathy

This study is currently recruiting participants.
Verified June 2013 by Medical University of Graz
Sponsor:
Collaborator:
Abbott Diagnostics Division
Information provided by (Responsible Party):
Gernot Schilcher, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01292317
First received: February 8, 2011
Last updated: June 4, 2013
Last verified: June 2013
History of Changes
  Purpose

Introduction:

Patients with pre-existing impaired renal function are prone to develop acute contrast media induced nephropathy (CIN). Neutrophil gelatinase-associated Lipocalin (NGAL), a new biomarker predictive for acute renal injury has been shown to be capable for earlier diagnosis of acute contrast media induced nephropathy (CIN) in patients undergoing cardiac surgery.

Intravenous volume load is a widely accepted prophylaxis.

In this randomized and controlled study, only patients with the need for an intra-arterial contrast media (CM) application will be included and receive a standardized, weight-based, intravenous hydration before investigation.

It is the aim of this study:

  1. to evaluate the magnitude of a risk for contrast media induced nephropathy (CIN) following intra-arterial angiography in a well defined group of high-risk patients.
  2. to use urinary Neutrophil gelatinase-associated Lipocalin (NGAL) as an early predictor of contrast media induced nephropathy (CIN) after contrast media (CM) application.
  3. to evaluate the clinical benefit of an early post-procedural i.v. hydration as compared to only pre-procedural volume expansion.

Patients with markedly increased urinary Neutrophil gelatinase-associated Lipocalin (NGAL) after investigation will be randomized into one of two study groups:

Patients of Group A will undergo standard treatment consisting of unrestricted oral fluid intake.

Patients of Group B will additionally receive 3-4 ml/kg BW/h 0.9 % saline intravenously for 6 hours.

Endpoints:

Primary endpoint: contrast media induced nephropathy (CIN) defined by an increase greater than 25% of baseline serum creatinine.

Secondary endpoint: NGAL, Cystatin C, and creatinine values, need for renal replacement therapy, death.


Condition Intervention
Contrast Media Induced Nephropathy (CIN)
 Other: application of intravenous volume
Other: oral fluid application

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Early Detection and Intervention of Acute Contrast Media Induced Nephropathy Using Neutrophil Gelatinase-associated Lipocalin (NGAL) May Improve Renal Outcome: A Study in Patients Undergoing Intra-arterial Angiography.

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Contrast media induced nephropathy (CIN) defined by an increase greater than 25% of baseline serum creatinine. [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: January 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: intravenous hydration
intravenous application of 0.9% saline
 Other: application of intravenous volume
weight based intravenous application of volume
Active Comparator: oral hydration only Other: oral fluid application
oral fluid application

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with the need for intra-arterial angiography/angioplasty
  • Patients older than 18 years
  • Patients with clinically stable chronic renal insufficiency stage 2 and more (calculated GFR < 70 ml/min/1,73 m2)(65)
  • Written informed consent

Exclusion Criteria:

  • Pre-existing clinical and/or laboratory evidence of acute renal failure at the time of enrollment
  • Evidence of rhabdomyolysis
  • Patients on renal replacement therapy (34)
  • Patients with life-threatening underlying disease (sepsis, MOF, SIRS)
  • Contraindication for volume therapy
  • Pregnancy
  • Contrast media application within 7 days prior to intervention
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292317

Contacts
Contact: Joerg Horina, MD +43 316 385 ext 12170 joerg.horina@medunigraz.at

Locations
Austria
Department of Medicine, Division of Nephrology Recruiting
Graz, Styria, Austria, 8036
Contact: Joerg Horina, MD     +43 316 385 ext 12170     joerg.horina@klinikum-graz.at    
Principal Investigator: Joerg Horina, MD            
Sponsors and Collaborators
Medical University of Graz
Abbott Diagnostics Division
Investigators
Principal Investigator: Joerg Horina, MD Medical University of Graz
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gernot Schilcher, MD, Joerg Horina, Professor of Medicine, Medical University of Graz, Medical University of Graz
ClinicalTrials.gov Identifier: NCT01292317     History of Changes
Other Study ID Numbers: CIN and NGAL 1.0, Ek 21-278 ex 09/10
Study First Received: February 8, 2011
Last Updated: June 4, 2013
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Graz:
NGAL
neutrophil gelatinase-associated Lipocalin
contrast media nephropathy
CIN
 volume expansion
acute kidney injury
contrast media

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on June 18, 2013