CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 520 enrolled
Drug / intervention
Sodium bicarbonate plus NAC +1 moredrug
Likely dose
Sodium bicarbonate plus NAC 3 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01218178
NCT01218178N/ACompleted
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BIcarbonato di Sodio e N-Acetilcisteina Nella Prevenzione Della Nefropatia da Mezzo di Contrasto Nell'infaRto mIocardico acutO(Registro BINARIO)

Catholic University of the Sacred Heart·observational·Posted Oct 11, 2010·Updated Mar 13, 2015

In Brief

An observational study evaluating Sodium bicarbonate plus NAC and Saline hydration plus NAC for Acute Myocardial Infarction and Acute Kidney Injury. Completed, enrolled 520 participants across 1 site.

Detailed Summary

Contrast-induced nephropathy (CIN) represents a potential complication of diagnostic and therapeutic procedures in interventional cardiology, especially in the acute setting of primary PCI. The investigators will test the efficacy of sodium bicarbonate (NaHCO3) and N-acetylcysteine (NAC) on the prevention of acute events and CIN in patients with acute myocardial infarction.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myocardial Infarction, Acute Kidney Injury
CountriesItaly
CollaboratorsPoliclinico Casilino ASL RMB

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 11, 2010
Enrollment StartJun 1, 2008
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 15.7 years ago

Interventions

Sodium bicarbonate plus NACdrug

154 mEq/L sodium bicarbonate (infusion rate of 3 ml/Kg for 1 hour followed by 1 ml/Kg for 6 hours) plus NAC (1200 mg bid for 48 hours)

Saline hydration plus NACdrug

0.9% saline (1 ml/Kg for 12 hours) plus NAC (1200 mg bid for 48 hours)