drugset / Trial / NCT02483143

NAC, NaHCO3 and NS Prophylaxis for CTPA in the ED on Suspicion of PE: A Randomized Controlled Trial

NCT02483143

Phase 4 Completed 231 enrolled Karadeniz Technical University
RandomizedParallel-groupTriple-blindPrevention

Summary

Study objective: The purpose of this study was to compare the role of the prophylactic protocols N-acetylcysteine (NAC) plus normal saline, sodium bicarbonate (NaHCO3) plus normal saline and intravenous normal saline (NS) alone in the prevention of contrast-induced nephropathy (CIN) after computed tomography pulmonary angiography (CTPA) in emergency patients with suspected pulmonary embolism (PE). Materials and methods: This study was planned as randomized, double blind, placebo controlled clinical research. Patients presenting to the emergency department within a 1-year period, undergoing CTPA on suspicion of PE and having one or more risk factors for development of CIN were included in the study. The NAC group received 1 ml/3 mgr NAC+NS solution 1 h before CTPA and 1 ml/kg per hour for a minimum 6 h after CTPA. The NaHCO3 group received 132 mEq NaHCO3+NS solution for 1 h before CTPA and 1 ml/kg per hour for a minimum of 6h after CTPA. The normal saline (NS) group received 3 ml/kg NS for 1 h before CTPA and 1 ml/kg per hour NS for a minimum 6 h after CTPA. CIN was evaluated as the primary outcome, and moderate renal injury (defined as a 100% increase in serum creatinine levels), severe renal insufficiency requiring hemodialysis or peritoneal dialysis) or in-hospital mortality as secondary outcomes.

Timeline

Start
2014-02
Primary completion
2015-02
Completion
2015-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator NAC Unknown 3 g Intravenous
Comparator sodium bicarbonate Diagnostic / imaging agent 132 meq Intravenous

Indications