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

• Sponsor: Odense University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01160627
• Collaborator: (none)
• Enrollment: 720
• Location: 1
• Arms: 4
• Duration (Months): 35
• Patients Per Site Per Month: 20.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Contrast Induced Nephropathy	Other: Hydration; Drug: Acetylcysteine; Drug: Sodium bicarbonate; Drug: Combined Acetylcystein and Sodium Bicarbonate	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 720 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Prevention of Contrast-induced Nephropathy in Patients With Acute Myocardial Infarction
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard treatment Hydration	Other: Hydration; Saline hydration
Active Comparator: Combined Acetylcystein and Sodium Bicarbonat	Drug: Combined Acetylcystein and Sodium Bicarbonate; Sodium bicarbonate 500 ml followed by 100 ml/hour for 5 hours combined with acetylcystein tablets for 2 days
Active Comparator: Sodium Bicarbonate	Drug: Sodium bicarbonate; Sodium bicarbonate 500 ml followed by 100 ml/hour for 5 hours
Active Comparator: Acetylcystein for 2 days Standard treatment + acetylcystein for 2 days	Drug: Acetylcysteine; Acetylcystein tablets for 2 days

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• STEMI patients treated with primary PCI

Exclusion Criteria:

• Cardiogenic shock

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Odense University Hospital	Odense		Denmark	5000

Sponsors and Collaborators

• Odense University Hospital

Investigators

• Principal Investigator: Per Thayssen, MD DMSci, Odense University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lisette Okkels Jensen, MD DMSci PhD, Odense University Hospital
• ClinicalTrials.gov Identifier: NCT01160627
• Other Study ID Numbers: CIN in STEMI
• First Posted: Jul 12, 2010
• Last Update Posted: Mar 22, 2013
• Last Verified: Mar 1, 2013

• Keywords provided by Lisette Okkels Jensen, MD DMSci PhD, Odense University Hospital: CIN STEMI
• Additional relevant MeSH terms: Kidney Diseases; Myocardial Infarction; Infarction; Acetylcysteine; N-monoacetylcystine

Study Results

No Results Posted as of Mar 22, 2013