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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT00908843
First received: May 25, 2009
Last updated: June 7, 2012
Last verified: June 2012

May 25, 2009
June 7, 2012
September 2008
June 2012   (final data collection date for primary outcome measure)
To compare the efficacy of oral versus intravenous hydration in the prevention of the contrast-induced nephropathy (CIN) in inpatients with different renal function. [ Time Frame: 24 h ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00908843 on ClinicalTrials.gov Archive Site
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). [ Time Frame: 24 h ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Prevention of Contrast Induced Nephropathy (NIC) by Intravenous Versus Oral Rehydration
Comparative Efficacy of the Application of an Oral/iv Hydration Protocol in the Prevention of Contrast Induced Nephropathy

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

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
KIDNEY FAILURE, ACUTE
  • 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
  • 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).
  • 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
    Intervention: Other: Intravenous hydration with bicarbonate
  • 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).
    Intervention: Other: Oral hydration with Sodium solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
167
June 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00908843
NIC2117, 2117/2007, EC08/00203
No
Clinica Universidad de Navarra, Universidad de Navarra
Clinica Universidad de Navarra, Universidad de Navarra
Not Provided
Study Director: Nuria García-Fernández, MD, Ph.D. Clínica Universidad de Navarra
Clinica Universidad de Navarra, Universidad de Navarra
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP