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
  Purpose

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


Condition Intervention
KIDNEY FAILURE, ACUTE
Other: Intravenous hydration with bicarbonate
Other: Oral hydration with Sodium solution

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Clinica Universidad de Navarra, Universidad de Navarra:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 167
Study Start Date: September 2008
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00908843

Locations
Spain
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
  More Information

No publications provided

Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT00908843     History of Changes
Other Study ID Numbers: NIC2117, 2117/2007, EC08/00203
Study First Received: May 25, 2009
Last Updated: June 7, 2012
Health Authority: Spain: Spanish Agency of Medicines

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
Urologic Diseases
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014