Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate

Sponsor

Barretos Cancer Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00540904

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Radiographic Contrast Agent Nephropathy	Drug: sodium bicarbonate Drug: NaCl	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate

Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Aug 1, 2008

Actual Study Completion Date :

Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: sodium bicarbonate Solution 154 mEq/L of sodium bicarbonate	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.
Active Comparator: Sodium chloride Solution of 154 mEq/L of NaCl	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.

Arm

Intervention/Treatment

Active Comparator: sodium bicarbonate

Solution 154 mEq/L of sodium bicarbonate

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.

Active Comparator: Sodium chloride

Solution of 154 mEq/L of NaCl

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital do Cancer de Barretos - Fundação PIO XII	Barretos	São Paulo	Brazil	14784-400

Sponsors and Collaborators

Barretos Cancer Hospital

Investigators

Principal Investigator: Ricardo G Silva, MD, Hospital do Cancer de Barretos - Fundação PIO XII

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Barretos Cancer Hospital

ClinicalTrials.gov Identifier:

NCT00540904

Other Study ID Numbers:

1-Silva

First Posted:

Oct 8, 2007

Last Update Posted:

Mar 3, 2014

Last Verified:

Feb 1, 2014

Keywords provided by Barretos Cancer Hospital

Additional relevant MeSH terms:

Kidney Diseases

Study Results

No Results Posted as of Mar 3, 2014