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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
Barretos Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Radiographic Contrast Agent Nephropathy focused on measuring contrast, nephropathy, bicarbonate, prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
October 5, 2007
Last Updated
February 27, 2014
Sponsor
Barretos Cancer Hospital
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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.
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Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate

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