Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate

NCT00540904 | Completed Phase 2 DMC

• 1 other identifier: 1-Silva
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiographic Contrast Agent Nephropathy

Keywords

contrast; nephropathy; bicarbonate; prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

sodium bicarbonate

ACTIVE COMPARATOR

Solution 154 mEq/L of sodium bicarbonate

Drug: sodium bicarbonate

Sodium chloride

ACTIVE COMPARATOR

Solution of 154 mEq/L of NaCl

Drug: NaCl

Interventions

sodium bicarbonate DRUG

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.

sodium bicarbonate

NaCl DRUG

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.

Sodium chloride

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barretos Cancer Hospital: lead

Study Sites (1)

Hospital do Cancer de Barretos - Fundação PIO XII

Barretos, São Paulo, 14784-400, Brazil

Location

Related 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 May 19;291(19):2328-34. doi: 10.1001/jama.291.19.2328.

  PMID: 15150204 RESULT

MeSH Terms

Conditions

Kidney Diseases

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ricardo G Silva, MD

  Hospital do Cancer de Barretos - Fundação PIO XII

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2007
• First Posted: October 8, 2007
• Study Start: September 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: September 1, 2009
• Last Updated: March 3, 2014

Record last verified: 2014-02

Locations

BR (1)