Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate

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.

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Key information

Conditions

Radiographic Contrast Agent Nephropathy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital do Cancer de Barretos - Fundação PIO XII

Barretos, São Paulo, 14784-400, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

Time frame: 2 days

Secondary outcomes

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

Time frame: 2 days

Sponsors and collaborators

Lead sponsor

Barretos Cancer Hospital

Other

Registry information

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2009
First posted: Oct 8, 2007
Registry last updated: Mar 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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