Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate
Primary Purpose
Radiographic Contrast Agent Nephropathy
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
sodium bicarbonate
NaCl
Sponsored by
About this trial
This is an interventional prevention trial for Radiographic Contrast Agent Nephropathy focused on measuring contrast, nephropathy, bicarbonate, prevention
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
Sites / Locations
- Hospital do Cancer de Barretos - Fundação PIO XII
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
sodium bicarbonate
Sodium chloride
Arm Description
Solution 154 mEq/L of sodium bicarbonate
Solution of 154 mEq/L of NaCl
Outcomes
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
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
Full Information
NCT ID
NCT00540904
First Posted
October 5, 2007
Last Updated
February 27, 2014
Sponsor
Barretos Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00540904
Brief Title
Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate
Official Title
Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barretos Cancer Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiographic Contrast Agent Nephropathy
Keywords
contrast, nephropathy, bicarbonate, prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sodium bicarbonate
Arm Type
Active Comparator
Arm Description
Solution 154 mEq/L of sodium bicarbonate
Arm Title
Sodium chloride
Arm Type
Active Comparator
Arm Description
Solution of 154 mEq/L of NaCl
Intervention Type
Drug
Intervention Name(s)
sodium bicarbonate
Intervention Description
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
Intervention Name(s)
NaCl
Intervention Description
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 Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo G Silva, MD
Organizational Affiliation
Hospital do Cancer de Barretos - Fundação PIO XII
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital do Cancer de Barretos - Fundação PIO XII
City
Barretos
State/Province
São Paulo
ZIP/Postal Code
14784-400
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
15150204
Citation
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.
Results Reference
result
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Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate
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