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

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

Detailed Description
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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).

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

Conditions
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KIDNEY FAILURE, ACUTE

Intervention / Treatment
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* Other: Intravenous hydration with bicarbonate
* Other: Oral hydration with Sodium solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized patients aged less than 18 years provision for the performance of IV contrast (120-150 ml) within 12-24 h. Exclusion Criteria: Nephropathy patients with stage 4-5 according to the classification of Chronic Kidney Disease (CKD) of the U.S. National Kidney Foundation's Kidney Disease Outcome Quality Initiative (NKF-KDOQI). The GFR is estimated by the formula Modification Diet Renal Diseases Study (MDRD). Patients undergoing: cardiac catheterization or other proceeding in contrast with the previous week, colonoscopy in 48 hours or have received prior nephrotoxic (aminoglycosides and / or certain chemotherapeutic agents) 24-48 hours before the test or in hours.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: (I) BICARBONATE INTRAVENOUS INFUSION<br>Intravenous hydration with bicarbonate 1/6 M intravenous infusion (3ml/Kg/h) one hour before the administration of intravenous contrast | Other: Intravenous hydration with bicarbonate<br>* Intravenous hydration with bicarbonate 1/6 M intravenous infusion (3ml/Kg/h) one hour before the administration of intravenous contrast<br>|
| Active Comparator: (II) ORAL SODIUM SOLUTION<br>Oral hydration with Sodium solution (Casen solution of rehydratation) in the 4 hours before of the intravenous contrast administration (75 ml/10 kg as equivalent to 0,25 g of sodium chloride /10 kg). | Other: Oral hydration with Sodium solution<br>* Oral hydration with Sodium solution (Casen solution of rehydration) in the 4 hours before of the intravenous contrast administration (75 ml/10 kg as equivalent to 0,25 g of sodium chloride /10 kg).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficacy of oral versus intravenous hydration in the prevention of the contrast-induced nephropathy (CIN) in inpatients with different renal function. |  | 24 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study in vitro, the effect of contrast on NADPH-oxidase activity of PBLs isolated from 30 patients will be included in the study (10 patients by each group). |  | 24 h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contrast nephropathy, Renal failure