Sodium Bicarbonate and N-Acetylcysteine for Nephroprotection in Acute Myocardial Infarction
NCT01218178 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 520
Last updated 2015-03-13
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
- Acute Myocardial Infarction
- Acute Kidney Injury
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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