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

• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra (Other)
• Overall Status: Completed
• CT.gov ID: NCT00908843
• Collaborator: (none)
• Enrollment: 167
• Location: 1
• Arms: 2
• Duration (Months): 45
• Patients Per Site Per Month: 3.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
KIDNEY FAILURE, ACUTE	Other: Intravenous hydration with bicarbonate; Other: Oral hydration with Sodium solution	N/A

Detailed 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

• Study Type: Interventional
• Actual Enrollment: 167 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Comparative Efficacy of the Application of an Oral/iv Hydration Protocol in the Prevention of Contrast Induced Nephropathy
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: (I) BICARBONATE INTRAVENOUS INFUSION 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; Intravenous hydration with bicarbonate 1/6 M intravenous infusion (3ml/Kg/h) one hour before the administration of intravenous contrast
Active Comparator: (II) ORAL SODIUM SOLUTION 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; 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).

Outcome Measures

Primary Outcome Measures

1. 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

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinica Universidad de Navarra	Pamplona	Navarra	Spain	31008

Sponsors and Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra

Investigators

• Study Director: Nuria García-Fernández, MD, Ph.D., Clínica Universidad de Navarra

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
• ClinicalTrials.gov Identifier: NCT00908843
• Other Study ID Numbers: NIC2117; 2117/2007; EC08/00203
• First Posted: May 27, 2009
• Last Update Posted: Jun 8, 2012
• Last Verified: Jun 1, 2012

• Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra: Contrast nephropathy; Renal failure
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency; Acute Kidney Injury

Study Results

No Results Posted as of Jun 8, 2012