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Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate

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ClinicalTrials.gov Identifier: NCT00540904
Recruitment Status : Completed
First Posted : October 8, 2007
Last Update Posted : March 3, 2014
Sponsor:
Information provided by (Responsible Party):
Barretos Cancer Hospital

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 Type : Interventional  (Clinical Trial)
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 : September 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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.




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Responsible Party: Barretos Cancer Hospital
ClinicalTrials.gov Identifier: NCT00540904     History of Changes
Other Study ID Numbers: 1-Silva
First Posted: October 8, 2007    Key Record Dates
Last Update Posted: March 3, 2014
Last Verified: February 2014

Keywords provided by Barretos Cancer Hospital:
contrast
nephropathy
bicarbonate
prevention

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases