Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate

Phase 2

Completed

• Conditions: Radiographic Contrast Agent Nephropathy
• Interventions: Drug: sodium bicarbonate; Drug: NaCl

• Registration Number: NCT00540904
• Lead Sponsor: Barretos Cancer Hospital

Brief Summary

Contrast induced nephropathy is a rising cause of acute renal failure in all patients. A study published in JAMA 2004, show a superiority of a hydratation with sodium bicarbonate in comparison with the same volume hydratation with sodium bicarbonate. The investigators will try following the original protocol making 2 randomized groups of patients, with cancer diagnosis, \>18 years old, with a GFR \<60 and \>30 ml/min/1,73m2 by MDRD formula and/or diabetic patients. In the group 1 the patients will receive a solution with 154 mEq/L of a sodium bicarbonate, 3 cc/Kg/h at 1 hour before the injection of contrast and 1 cc/Kg/h during and 6 hours before the injection. The primary end point will be the rise of 25% or more in creatinine or dialysis needed.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-10-05
• Study First Submitted QC: 2007-10-05
• Study First Posted: 2007-10-08
• Primary Completion: 2008-08
• Study Completion: 2009-09
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-27
• Last Update Posted: 2014-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• > 18 years old
• cancer diagnosis
• GFR < 60 and > 30 ml/min/1,73m2 by MDRD formula or diabetic
• CT with contrast

Exclusion Criteria

• dialysis needed
• uncontrolled hypertension
• changes in serum creatinine levels of at least 0.5 mg/dl during the previous 24 hours of procedure
• recent exposure to radiographic contrast agents (within previous two days of the study)
• administration of dopamine, mannitol , fenoldopam or N-Acetyl Cystein during the intended time of study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sodium bicarbonate	sodium bicarbonate	Solution 154 mEq/L of sodium bicarbonate
Sodium chloride	NaCl	Solution of 154 mEq/L of NaCl

Primary Outcome Measures

Name	Time	Method
Development of contrast-induced nephropathy, defined as an increase in serum creatinine of 25% or more within 2 day after administration of contrast or dialysis needed	2 days

Secondary Outcome Measures

Name	Time	Method
change in serum bicarbonate change in serum potassium change in serum glucose change in serum creatinine change in estimated glomerular filtration rate incidence of contrast induced nephropathy comparison of cholesterol level	2 days

Trial Locations

Locations (1)

Hospital do Cancer de Barretos - Fundação PIO XII; 🇧🇷 Barretos, São Paulo, Brazil