Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Barretos Cancer Hospital
ClinicalTrials.gov Identifier:
NCT00540904
First received: October 5, 2007
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Radiographic Contrast Agent Nephropathy
Drug: sodium bicarbonate
Drug: NaCl
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate

Resource links provided by NLM:


Further study details as provided by Barretos Cancer Hospital:

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 [ Time Frame: 2 days ] [ Designated as safety issue: No ]

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 [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: September 2007
Study Completion Date: September 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00540904

Locations
Brazil
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
  More Information

Publications:
Responsible Party: Barretos Cancer Hospital
ClinicalTrials.gov Identifier: NCT00540904     History of Changes
Other Study ID Numbers: 1-Silva
Study First Received: October 5, 2007
Last Updated: February 27, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Barretos Cancer Hospital:
contrast
nephropathy
bicarbonate
prevention

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 24, 2014