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Prevention of Contrast Induced Nephropathy (NIC) by Intravenous Versus Oral Rehydration — NIC  

KIDNEY FAILURE, ACUTE Clinical Trial

Official title:
Comparative Efficacy of the Application of an Oral/iv Hydration Protocol in the Prevention of Contrast Induced Nephropathy

Clinical Trial Summary

The purpose of this study is to compare the efficacy of oral versus intravenous hydration in the prevention of the contrast-induced nephropathy.

Clinical Trial Description

Objective: To compare the efficacy of oral versus intravenous hydration in the prevention of the contrast-induced nephropathy (CIN) in inpatients with different renal function and equal type and volume of contrast.

Methods: The clinical trial will include 324 patients with GFR higher or equal to 30 ml/min who will receive intravenous contrast (Iohexol: 300 mg of l/ml; approximate volume: 120 ml at 2-5ml/second) in the following 12-24 hours. Patients with inclusion criteria, and having previously signed a consent form, will be randomised into 3 groups (intravenous hydration, oral and no hydration). Intravenous hydration will be carried out with bicarbonate 1/6M one hour before the test (3ml/Kg/h) and oral hydration with Casen solution in will be carried out 4 hours before (75 ml/10 kg) the intravenous contrast administration. In relation to the hydrated, it should be pointed out that, the same procedure would have been carried out without the study. The follow-up of renal function will be carried out after measuring creatinine and cystatin C in blood and GFR pre- and 24 hour after the test. It will also determine neutrophil gelatinase-associated lipocalin (N-GAL), IL-8 and F2-Isoprostanes levels in urine and superoxide dismutase activity in erythrocytes, pre- and in different post- test times.

Also, in vitro, the effect of contrast on NADPH-oxidase activity of PBLs isolated from 30 control patients will also be studied (10 patients by each group). ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00908843
Study type Interventional
Source Clinica Universidad de Navarra, Universidad de Navarra
Contact
Status Completed
Phase N/A
Start date September 2008
Completion date June 2012
View Details
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