Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00540904

Enrollment

Registered

2007-10-08

Start date

2007-09-30

Completion date

2009-09-30

Last updated

2014-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiographic Contrast Agent Nephropathy

Keywords

contrast, nephropathy, bicarbonate, prevention

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.

Interventions

DRUGsodium 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.

DRUGNaCl

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026