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

Contrast Induced Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01160627
• Other study ID #: CIN in STEMI
• Status: Completed
• Phase: N/A
• First received: July 9, 2010
• Last updated: March 21, 2013
• Start date: April 2010
• Est. completion date: March 2013

Study information

• Verified date: March 2013
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: Ethics CommitteeDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 720
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• STEMI patients treated with primary PCI

Exclusion Criteria:

• Cardiogenic shock

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contrast Induced Nephropathy
• Kidney Diseases
• Myocardial Infarction

Intervention

Other:
• Hydration
Saline hydration

Drug:
• Acetylcysteine
Acetylcystein tablets for 2 days
• Sodium bicarbonate
Sodium bicarbonate 500 ml followed by 100 ml/hour for 5 hours
• Combined Acetylcystein and Sodium Bicarbonate
Sodium bicarbonate 500 ml followed by 100 ml/hour for 5 hours combined with acetylcystein tablets for 2 days

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of contrast induced nephropathy in STEMI patients treated with primary PCI	Rise in creatinine >25% from baseline to day 3	from baseline to day 3	Yes
Secondary	Prevention of contrast induced nephropathy in STEMI patients treated with primary PCI	Rise in creatinine >25% from baseline to day 30	from baseline to day 30	Yes