Trial | NCT00540904  Report issue

Official Title

Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    27
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.
Study Started
Sep 30
2007
Primary Completion
Aug 31
2008
Study Completion
Sep 30
2009
Last Update
Mar 03
2014
Estimate

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.

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.

sodium bicarbonate Active Comparator

Solution 154 mEq/L of sodium bicarbonate

Sodium chloride Active Comparator

Solution of 154 mEq/L of NaCl

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
No Results Posted