A Phase 2 interventional study of sodium bicarbonate and NaCl in Radiographic Contrast Agent Nephropathy, sponsored by Barretos Cancer Hospital. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-03.
Sponsored by Barretos Cancer Hospital · Phase 2, Interventional, and Prevention
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 27 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
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Exclusion Criteria:
Solution 154 mEq/L of sodium bicarbonate
Drug: sodium bicarbonate
Solution of 154 mEq/L of NaCl
Drug: NaCl
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.
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.
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
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
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Barretos Cancer Hospital