Neutrophil Gelatinase-associated Lipocalin (NGAL) and Contrast Media Induced Nephropathy
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:
- 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.
- to use urinary Neutrophil gelatinase-associated Lipocalin (NGAL) as an early predictor of contrast media induced nephropathy (CIN) after contrast media (CM) application.
- 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.
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.
|Contrast Media Induced Nephropathy (CIN)||Other: application of intravenous volume Other: oral fluid application|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.|
- Contrast media induced nephropathy (CIN) defined by an increase greater than 25% of baseline serum creatinine. [ Time Frame: 4 days ]
|Study Start Date:||January 2011|
|Study Completion Date:||December 2015|
|Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292317
|Department of Medicine, Division of Nephrology|
|Graz, Styria, Austria, 8036|
|Principal Investigator:||Joerg Horina, MD||Medical University of Graz|