CompletedNot Applicable

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

Austria819 participantsStarted 2011-01

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Contrast media induced nephropathy (CIN) defined by an increase greater than 25% of baseline serum creatinine.

Timeframe: 4 days

Trial details

NCT IDNCT01292317

SponsorMedical University of Graz

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-12

View on ClinicalTrials.gov More Contrast Media Induced Nephropathy (CIN) trials