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

NCT00908843 | Completed

• 3 other identifiers: NIC21172117/2007EC08/00203
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

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.

Conditions

KIDNEY FAILURE, ACUTE

Keywords

Contrast nephropathy; Renal failure

Outcome Measures

Primary Outcomes (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 Outcomes (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

Study Arms (2)

(I) BICARBONATE INTRAVENOUS INFUSION

EXPERIMENTAL

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

(II) ORAL SODIUM SOLUTION

ACTIVE COMPARATOR

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

Interventions

Intravenous hydration with bicarbonate OTHER

Intravenous hydration with bicarbonate 1/6 M intravenous infusion (3ml/Kg/h) one hour before the administration of intravenous contrast

(I) BICARBONATE INTRAVENOUS INFUSION

Oral hydration with Sodium solution OTHER

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).

(II) ORAL SODIUM SOLUTION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized patients
• aged less than 18 years
• provision for the performance of IV contrast (120-150 ml) within 12-24 h.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency

Interventions

Bicarbonates

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Anions; Ions; Electrolytes

Study Officials

• Nuria García-Fernández, MD, Ph.D.

  Clínica Universidad de Navarra

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2009
• First Posted: May 27, 2009
• Study Start: September 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 8, 2012

Record last verified: 2012-06

Locations

ES (1)