Abstract
BackgroundPatients 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/DesignThe 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.DiscussionA 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.Trial registrationClinicalTrials.gov NCT01292317
Highlights
Patients with pre-existing impaired renal function are prone to develop acute contrast media induced nephropathy (CIN)
A volume expansion strategy showing a benefit from earlier intervention for patients with markedly elevated urinary Neutrophil gelatinase-associated lipocalin (NGAL) values, indicating a CIN, might arise from data from this study
While contrast-enhanced procedures are fairly safe in the healthy population, patients with pre-existing impaired renal and/or cardiac function are prone to develop acute kidney injury (AKI) due to acute contrast induced nephropathy (CIN) and so have a greater risk of death [2,3]
Summary
The growing demand for sophisticated diagnostics in all fields of modern medicine has increased the need for contrast-enhanced imaging [1]. All patients requiring intra-arterial CM application will receive a weight-based, standardized intravenous hydration before investigation This measure of controlled pre-hydration alone might be of great benefit for our patients and differs from routine clinical practice, where patients often only receive oral fluid at best. To investigate the effect of a well-timed and intensified post-procedural volume expansion on renal function, morbidity and mortality in patients predicted to develop CIN according to NGAL testing. To compare the value of the MDRD, the CKDEPI- and the Cockcroft-Gault formula in this particular patient group At this stage, little is known about the beneficial effect of earlier diagnosis and subsequent intervention by volume expansion on AKI due to a rise in urinary NGAL. We are currently recruiting patients for this non-commercial investigator initiated trial to elucidate CIN
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