drugset / Trial / NCT00540904

Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate

NCT00540904

Phase 2 Completed 27 enrolled Barretos Cancer Hospital
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2007-09
Primary completion
2008-08
Completion
2009-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator sodium bicarbonate Diagnostic / imaging agent 154 meq Intravenous
Comparator sodium chloride Unknown 0.9 % Intravenous
Comparator sodium chloride Unknown 154 meq Intravenous

Indications

No indication recorded.