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Aminophylline and Contrast Induced Nephropathy in Acute Myocardial Infarction

NCT01594489 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2012-10-30

No results posted yet for this study

Summary

The purpose of this study is to determine whether additional therapy with Aminophylline to hydration with sodium bicarbonate and administration of N-acetylcysteine is more effective to prevent contrast induced acute kidney injury in patients undergoing primary coronary intervention for acute ST elevation myocardial infarction.

Conditions

Interventions

DRUG

Aminophylline

* 200 mg of aminophylline administrated intravenously as a short infusion, started in emergency department, before primary angioplasty and contrast medium administration * Sodium bicarbonate (154 mEq/L in dextrose and H20) 3mL/kg for 1 hour before contrast medium, followed by an infusion of 1 mL/kg/h for 12 hours after procedure * N-acetilcysteine: intravenous bolus of 1200 mg before angioplasty and 1200 mg twice daily for the 48 hours after PCI

DRUG

Hydration plus N-acetylcisteine

* Sodium bicarbonate (154 mEq/L in dextrose and H20) 3mL/kg for 1 hour before contrast medium, followed by an infusion of 1 mL/kg/h for 12 hours after procedure * N-acetilcysteine: intravenous bolus of 1200 mg before angioplasty and 1200 mg twice daily for the 48 hours after PCI

Sponsors & Collaborators

  • Ospedale Misericordia e Dolce

    lead OTHER

Principal Investigators

  • Mauro Maioli, MD · Cardiology Unit, Misericordia e Dolce Hospital, Prato, Italy

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • Italy

Study Locations

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Entities

Diseases

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 NCT01594489 on ClinicalTrials.gov