Neutrophil Gelatinase-associated Lipocalin (NGAL) and Contrast Media Induced Nephropathy
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|ClinicalTrials.gov Identifier: NCT01292317|
Recruitment Status : Completed
First Posted : February 9, 2011
Last Update Posted : March 18, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Contrast Media Induced Nephropathy (CIN)||Other: application of intravenous volume Other: oral fluid application||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||819 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
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
- Contrast media induced nephropathy (CIN) defined by an increase greater than 25% of baseline serum creatinine. [ Time Frame: 4 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01292317
|Department of Medicine, Division of Nephrology|
|Graz, Styria, Austria, 8036|
|Principal Investigator:||Joerg Horina, MD||Medical University of Graz|