Contrast Media Induced Nephropathy (CIN) Clinical Trial
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.
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.
Introduction:
Over the last decades the growing demand for appropriate diagnosing and intervention in all
fields of modern medicine has increased the necessity for use of iodinated contrast media
(CM). Patients with pre-existing impaired renal function are prone to develop acute contrast
media induced nephropathy (CIN) and consecutively have a greater risk of death.
To date, a reliable laboratory value or test that recognizes acute renal damage before serum
creatinine increases is still sought for. It would be a most helpful tool to initiate proper
treatment on time. Neutrophil gelatinase-associated Lipocalin (NGAL), a new biomarker
predictive for acute renal injury has been shown to be capable for earlier diagnosis of
contrast media induced nephropathy (CIN) in patients undergoing cardiac surgery.
So far, an intravenous volume load is the only fairly proven and widely accepted
prophylaxis. However, the optimal intravenous fluid regimen regarding the type, amount,
route and duration of volume application has remained controversial. Habits of giving pre-
and post-procedural volume have been widely differing throughout all randomized trials and,
thus, are not comparable in the available studies. Unfortunately, most studies were also
lacking statistical power, used different types of contrast media (CM) and definitions of
contrast media induced nephropathy (CIN) or allowed for additional prophylactic measures,
such as N-acetylcysteine or sodium bicarbonate in a varying percentage of their patients.
In our randomized and controlled study, only patients with the need for an intra-arterial
contrast media (CM) application will be included. Patients scheduled for a diagnostic
angiography and/or endovascular intervention will receive a standardized, weight-based,
intravenous hydration before investigation. Only one type of contrast media (CM) and neither
sodium bicarbonate, nor N-acetylcysteine is used throughout the study. The study will be
performed according to the Consort-Statement 2010 for clinical trials.
It is the aim of our 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 Neutrophil gelatinase-associated Lipocalin (NGAL) values
(criteria for randomization into one of two treatment groups see below) at 4 to 6 hours
after investigation will be randomized into one of two study groups:
Patients of Group A will additionally receive 3-4 ml/kg BW/h 0.9 % saline intravenously for
6 hours.
Patients of Group B will undergo standard treatment consisting of unrestricted oral fluid
intake, at least 500 ml tea or water provided by the ward, but no intravenous fluid
application.
Criteria for Randomization (after 2nd NGAL testing):
- Patients with NGAL levels > 150 ng/ml, if baseline was below 75 ng/ml.
- Patients with doubling of NGAL values, if baseline was between 75 and 150 ng/ml.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention