Safety Study Of N-Acetylcysteine For Prevention Of Contrast Induced Nephropathy In Patients w/Stage 3 Renal Failure
Status:
Terminated
Trial end date:
2014-09-15
Target enrollment:
Participant gender:
Summary
This will be a randomized prospective dose escalation clinical study of N-acetylcysteine
(NAC) in patients with stage 3 or worse renal failure (Glomerular Filtration Rate 30-60
ml/min calculated with the Modification of Diet in Renal Disease formula), undergoing a
procedure or imaging that requires the administration of contrast media at Oregon Health &
Science University or the Portland Veterans Hospital. Subjects will receive NAC 60 minutes
prior to the procedure or imaging requiring contrast media. Toxicity will be graded according
to NCI Common Toxicity Criteria (CTC) version 3.0. An adult Phase 1 dose escalation study of
NAC administered intravenously (IV) and intra-arterially (IA) will be performed. An isotonic
nonionic contrast agent will be used in all cases. Contrast Induced Nephropathy (CIN) is
defined as an increase in serum creatinine concentration of 25% or more from the subjects
baseline value within a 72-hour period after the administration of contrast media. Serum
creatinine concentration will be measured at admission, every day during in-patient
hospitalization, and at hospital discharge.