Prevention of Contrast-induced Nephropathy in Patients With Acute Myocardial Infarction

Not Applicable

Completed

• Conditions: Contrast Induced Nephropathy
• Interventions: Other: Hydration; Drug: Combined Acetylcystein and Sodium Bicarbonate; Drug: Sodium bicarbonate; Drug: Acetylcysteine

• Registration Number: NCT01160627
• Lead Sponsor: Odense University Hospital

Brief Summary

OBJECTIVE: To evaluate the efficacy of prevention of contrast induced nephropathy in patients with ST segment elevation myocardial infarction treated with primary percutaneous coronary intervention.

DESIGN: Prospective study. SETTING: Three-center study Acute kidney injury was defined as a rise in creatinine \>25% from baseline Serum creatinine will be measured at baseline and each day for the following 3 days and at 30 days.

Patients will be randomised to:

1. Standard treatment

2. Standard treatment + acetylcystein for 2 days

3. Standard treatment + Sodium bicarbonate 500 ml / followed by 100 ml/h for 5 hours

4. Standard treatment + acetylcystein for 2 days + Sodium bicarbonate 500 ml / followed by 100 ml/h for 5 hours

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-07-09
• Study First Submitted QC: 2010-07-09
• Study First Posted: 2010-07-12
• Status Verified: 2013-03
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Last Update Submitted: 2013-03-21
• Last Update Posted: 2013-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 720

Inclusion Criteria

• STEMI patients treated with primary PCI

Exclusion Criteria

• Cardiogenic shock

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard treatment	Hydration	Hydration
Combined Acetylcystein and Sodium Bicarbonat	Combined Acetylcystein and Sodium Bicarbonate	-
Sodium Bicarbonate	Sodium bicarbonate	-
Acetylcystein for 2 days	Acetylcysteine	Standard treatment + acetylcystein for 2 days

Primary Outcome Measures

Name	Time	Method
Prevention of contrast induced nephropathy in STEMI patients treated with primary PCI	from baseline to day 3	Rise in creatinine \>25% from baseline to day 3

Secondary Outcome Measures

Name	Time	Method
Prevention of contrast induced nephropathy in STEMI patients treated with primary PCI	from baseline to day 30	Rise in creatinine \>25% from baseline to day 30

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark