Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate

Radiographic Contrast Agent Nephropathy Clinical Trial

Official title:

Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00540904
• Other study ID #: 1-Silva
• Status: Completed
• Phase: Phase 2
• First received: October 5, 2007
• Last updated: February 27, 2014
• Start date: September 2007
• Est. completion date: September 2009

Study information

• Verified date: February 2014
• Source: Barretos Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Diseases
• Radiographic Contrast Agent Nephropathy

Intervention

Drug:
• sodium bicarbonate
IV 154 mEq/L sodium bicarbonate. Infusion of 3 cc/Kg/h 1 hour before the injection of contrast and 1 cc/Kg/h after the injection.
• NaCl
IV 154 mEq/L solution of NaCl 0.9%. Infusion of 3 cc/Kg/h 1 hour before the injection of contrast and 1 cc/Kg/h after the injection.

Locations

Country	Name	City	State
Brazil	Hospital do Cancer de Barretos - Fundação PIO XII	Barretos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Barretos Cancer Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Merten GJ, Burgess WP, Gray LV, Holleman JH, Roush TS, Kowalchuk GJ, Bersin RM, Van Moore A, Simonton CA 3rd, Rittase RA, Norton HJ, Kennedy TP. Prevention of contrast-induced nephropathy with sodium bicarbonate: a randomized controlled trial. JAMA. 2004 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No