Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate
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 Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate|
- 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 ]
- 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 ]
|Study Start Date:||September 2007|
|Study Completion Date:||September 2009|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
Active Comparator: 1
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: 2
Solution of 154 mEq/L of 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.
|Hospital do Cancer de Barretos - Fundação PIO XII|
|Barretos, São Paulo, Brazil, 14784-400|
|Principal Investigator:||Ricardo G Silva, MD||Hospital do Cancer de Barretos - Fundação PIO XII|