title: 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).
abstract: BACKGROUND
  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 kidney injury (AKI), has been shown to be useful for earlier diagnosis of CIN; however, urinary NGAL values may be markedly increased in chronic renal failure at baseline. Results from those studies suggested that urinary NGAL values may not be helpful for the clinician. An intravenous volume load is a widely accepted prophylactic measure and possibly a reasonable intervention to prevent deterioration of renal function. The aim of our study is to evaluate NGAL as an early predictor of CIN and to investigate the clinical benefit of early post-procedural i.v. hydration.
  
  
  METHODS
  The study will follow a prospective, open-label, randomized controlled design. Patients requiring intra-arterial contrast media (CM) application will be included and receive standardized, weight-based, intravenous hydration before investigation. Subjects with markedly increased urinary NGAL values after CM application will be randomized into one of two study groups. Group A will receive 3-4 ml/kg BW/h 0.9% saline intravenously for 6 hours. Group B will undergo only standard treatment consisting of unrestricted oral fluid intake. The primary outcome measure will be CIN defined by an increase greater than 25% of baseline serum creatinine. Secondary outcomes will include urinary NGAL values, cystatin C values, contrast media associated changes in cardiac parameters such as NT-pro-BNP/troponin T, changes in urinary cytology, need for renal replacement treatment, length of stay in hospital and death.We assume that 20% of the included patients will show a definite rise in urinary NGAL. Prospective statistical power calculations indicate that the study will have 80% statistical power to detect a clinically significant decrease of CIN of 40% in the treatment arm if 1200 patients are recruited into the study.
  
  
  CONCLUSIONS
  A volume expansion strategy showing a benefit from earlier intervention for patients with markedly elevated urinary NGAL values, indicating a CIN, might arise from data from this study.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01292317.
authors.affiliation: Division of Nephrology and Hemodialysis, Department of Internal Medicine, Medical University of Graz, Austria.
authors.forename: Gernot
authors.initials: G
authors.lastname: Schilcher
authors.forename: Werner
authors.initials: W
authors.lastname: Ribitsch
authors.forename: Ronald
authors.initials: R
authors.lastname: Otto
authors.forename: Rupert H
authors.initials: RH
authors.lastname: Portugaller
authors.forename: Franz
authors.initials: F
authors.lastname: Quehenberger
authors.forename: Martini
authors.initials: M
authors.lastname: Truschnig-Wilders
authors.forename: Robert
authors.initials: R
authors.lastname: Zweiker
authors.forename: Philipp
authors.initials: P
authors.lastname: Stiegler
authors.forename: Marianne
authors.initials: M
authors.lastname: Brodmann
authors.forename: Klemens
authors.initials: K
authors.lastname: Weinhandl
authors.forename: Joerg H
authors.initials: JH
authors.lastname: Horina
mesh_terms: D058186:Acute Kidney Injury / Q000139:chemically induced* / Q000000981:diagnostic imaging / Q000652:urine*; D000209:Acute-Phase Proteins / Q000096:biosynthesis / Q000652:urine*; D015415:Biomarkers / Q000652:urine; D002406:Catheterization, Peripheral; D003287:Contrast Media / Q000008:administration & dosage / Q000009:adverse effects*; D042241:Early Diagnosis; D006801:Humans; D007269:Injections, Intra-Arterial; D000071068:Lipocalin-2; D054834:Lipocalins / Q000096:biosynthesis / Q000652:urine*; D011446:Prospective Studies; D011518:Proto-Oncogene Proteins / Q000096:biosynthesis / Q000652:urine*; D011859:Radiography; D016896:Treatment Outcome
chemical_list: D000209:Acute-Phase Proteins; D015415:Biomarkers; D003287:Contrast Media; C489506:LCN2 protein, human; D000071068:Lipocalin-2; D054834:Lipocalins; D011518:Proto-Oncogene Proteins