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

NCT01292317 | Completed

• 2 other identifiers: CIN and NGAL 1.0Ek 21-278 ex 09/10
• Study Type: interventional
• Target: 819
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 3.to evaluate the clinical benefit of an early post-procedural i.v. hydration as compared to only pre-procedural volume expansion.

Conditions

Contrast Media Induced Nephropathy (CIN)

Keywords

NGAL; neutrophil gelatinase-associated Lipocalin; contrast media nephropathy; CIN; volume expansion; acute kidney injury; contrast media

Outcome Measures

Primary Outcomes (1)

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

  4 days

Study Arms (2)

intravenous hydration

ACTIVE COMPARATOR

intravenous application of 0.9% saline

Other: application of intravenous volume

oral hydration only

ACTIVE COMPARATOR

Other: oral fluid application

Interventions

application of intravenous volume OTHER

weight based intravenous application of volume

intravenous hydration

oral fluid application OTHER

oral fluid application

oral hydration only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead
• Abbott Diagnostics Division: collaborator

Study Sites (1)

Department of Medicine, Division of Nephrology

Graz, Styria, 8036, Austria

Location

Related Publications (5)

• Reddan D, Laville M, Garovic VD. Contrast-induced nephropathy and its prevention: What do we really know from evidence-based findings? J Nephrol. 2009 May-Jun;22(3):333-51.

  PMID: 19557710 BACKGROUND

• Haase-Fielitz A, Bellomo R, Devarajan P, Story D, Matalanis G, Dragun D, Haase M. Novel and conventional serum biomarkers predicting acute kidney injury in adult cardiac surgery--a prospective cohort study. Crit Care Med. 2009 Feb;37(2):553-60. doi: 10.1097/CCM.0b013e318195846e.

  PMID: 19114878 BACKGROUND

• McCullough PA, Wolyn R, Rocher LL, Levin RN, O'Neill WW. Acute renal failure after coronary intervention: incidence, risk factors, and relationship to mortality. Am J Med. 1997 Nov;103(5):368-75. doi: 10.1016/s0002-9343(97)00150-2.

  PMID: 9375704 BACKGROUND

• Ribitsch W, Schilcher G, Quehenberger F, Pilz S, Portugaller RH, Truschnig-Wilders M, Zweiker R, Brodmann M, Stiegler P, Rosenkranz AR, Pickering JW, Horina JH. Neutrophil gelatinase-associated lipocalin (NGAL) fails as an early predictor of contrast induced nephropathy in chronic kidney disease (ANTI-CI-AKI study). Sci Rep. 2017 Jan 27;7:41300. doi: 10.1038/srep41300.

  PMID: 28128223 DERIVED

• Schilcher G, Ribitsch W, Otto R, Portugaller RH, Quehenberger F, Truschnig-Wilders M, Zweiker R, Stiegler P, Brodmann M, Weinhandl K, Horina JH. Early detection and intervention using neutrophil gelatinase-associated lipocalin (NGAL) may improve renal outcome of acute contrast media induced nephropathy: a randomized controlled trial in patients undergoing intra-arterial angiography (ANTI-CIN Study). BMC Nephrol. 2011 Aug 17;12:39. doi: 10.1186/1471-2369-12-39.

  PMID: 21849080 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Joerg Horina, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Joerg Horina, Professor of Medicine, Medical University of Graz

Study Record Dates

• First Submitted: February 8, 2011
• First Posted: February 9, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 18, 2016

Record last verified: 2016-03

Locations

AU (1)