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

Odense University Hospital

Status: Completed

Conditions: Contrast Induced Nephropathy

Treatments: Other: Hydration; Drug: Acetylcysteine; Drug: Sodium bicarbonate; Drug: Combined Acetylcystein and Sodium Bicarbonate

Study type: Interventional

Funder types: Other

Identifiers

NCT01160627

CIN in STEMI

Details and patient eligibility

About

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

Enrollment: 720 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• STEMI patients treated with primary PCI

Exclusion criteria

• Cardiogenic shock

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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720 participants in 4 patient groups

Standard treatment

Active Comparator group

Description:

Hydration

Treatment:

Other: Hydration

Combined Acetylcystein and Sodium Bicarbonat

Active Comparator group

Treatment:

Drug: Combined Acetylcystein and Sodium Bicarbonate

Sodium Bicarbonate

Active Comparator group

Treatment:

Drug: Sodium bicarbonate

Acetylcystein for 2 days

Active Comparator group

Description:

Standard treatment + acetylcystein for 2 days

Treatment:

Drug: Acetylcysteine