Sodium Bicarbonate and N-Acetylcysteine for Nephroprotection in Acute Myocardial Infarction

NCT01218178 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 520

Last updated 2015-03-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Sodium bicarbonate plus NAC

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)

DRUG

Saline hydration plus NAC

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

Sponsors & Collaborators

  • Policlinico Casilino ASL RMB

    collaborator OTHER
  • Catholic University of the Sacred Heart

    lead OTHER

Principal Investigators

  • Antonio Maria Leone, MD, PhD · Catholic University of the Sacred Heart, Rome

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01218178 on ClinicalTrials.gov