drugset / Trial / NCT02761577

A Prospective Study on Incidence and Prevention of Contrast-induced Nephropathy in Croatia

NCT02761577

Phase 4 Completed 90 enrolled Clinical Hospital Centre Zagreb
RandomizedParallel-groupSingle-blindPrevention

Summary

The study is analysis of the incidence of contrast-induced nephropathy (CIN) in patients with previously normal renal function undergoing angiography and comparison between the three different treatment protocols on renal function. Patients are randomly assigned to the three groups: 1) peroral hydration, 2) Na bicarbonate (NaHCO3), and 3) NaHCO3 plus N-acetylcysteine (NAC) infusion. Serum creatinine (SCr), blood urea nitrogen (BUN), and neutrophil gelatinase-associated lipocalin (NGAL) are measured before and 48 hours after the angiography. CIN was defined as an absolute increase of 0.5 mg/dL or a relative increase of \>25% in creatinine levels 48-72 hours after the procedure

Timeline

Start
2012-06
Primary completion
2013-07
Completion
2016-04

Drugs

EvaluationDrugModalityDoseRoute
Subject N-acetylcysteine Small molecule 1200 mg Intravenous
Subject sodium bicarbonate Diagnostic / imaging agent 1 ml Intravenous

Indications