Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate

NCT ID: NCT00540904

Last Updated: 2014-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

sodium bicarbonate

Solution 154 mEq/L of sodium bicarbonate

Group Type: ACTIVE_COMPARATOR

sodium bicarbonate

Intervention Type: 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 chloride

Solution of 154 mEq/L of NaCl

Group Type: ACTIVE_COMPARATOR

NaCl

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Barretos Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ricardo G Silva, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital do Cancer de Barretos - Fundação PIO XII

Locations

Hospital do Cancer de Barretos - Fundação PIO XII

Barretos, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: RESULT

PMID: 15150204 (View on PubMed)

Other Identifiers

1-Silva

Identifier Type: -

Identifier Source: org_study_id