Prevention of Contrast-induced Nephropathy in Patients With Acute Myocardial Infarction
Primary Purpose
Contrast Induced Nephropathy
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Hydration
Acetylcysteine
Sodium bicarbonate
Combined Acetylcystein and Sodium Bicarbonate
Sponsored by
About this trial
This is an interventional prevention trial for Contrast Induced Nephropathy focused on measuring CIN STEMI
Eligibility Criteria
Inclusion Criteria:
- STEMI patients treated with primary PCI
Exclusion Criteria:
- Cardiogenic shock
Sites / Locations
- Odense University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Standard treatment
Combined Acetylcystein and Sodium Bicarbonat
Sodium Bicarbonate
Acetylcystein for 2 days
Arm Description
Hydration
Standard treatment + acetylcystein for 2 days
Outcomes
Primary Outcome Measures
Prevention of contrast induced nephropathy in STEMI patients treated with primary PCI
Rise in creatinine >25% from baseline to day 3
Secondary Outcome Measures
Prevention of contrast induced nephropathy in STEMI patients treated with primary PCI
Rise in creatinine >25% from baseline to day 30
Full Information
NCT ID
NCT01160627
First Posted
July 9, 2010
Last Updated
March 21, 2013
Sponsor
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01160627
Brief Title
Prevention of Contrast-induced Nephropathy in Patients With Acute Myocardial Infarction
Official Title
Prevention of Contrast-induced Nephropathy in Patients With Acute Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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:
Standard treatment
Standard treatment + acetylcystein for 2 days
Standard treatment + Sodium bicarbonate 500 ml / followed by 100 ml/h for 5 hours
Standard treatment + acetylcystein for 2 days + Sodium bicarbonate 500 ml / followed by 100 ml/h for 5 hours
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast Induced Nephropathy
Keywords
CIN STEMI
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
720 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard treatment
Arm Type
Active Comparator
Arm Description
Hydration
Arm Title
Combined Acetylcystein and Sodium Bicarbonat
Arm Type
Active Comparator
Arm Title
Sodium Bicarbonate
Arm Type
Active Comparator
Arm Title
Acetylcystein for 2 days
Arm Type
Active Comparator
Arm Description
Standard treatment + acetylcystein for 2 days
Intervention Type
Other
Intervention Name(s)
Hydration
Intervention Description
Saline hydration
Intervention Type
Drug
Intervention Name(s)
Acetylcysteine
Intervention Description
Acetylcystein tablets for 2 days
Intervention Type
Drug
Intervention Name(s)
Sodium bicarbonate
Intervention Description
Sodium bicarbonate 500 ml followed by 100 ml/hour for 5 hours
Intervention Type
Drug
Intervention Name(s)
Combined Acetylcystein and Sodium Bicarbonate
Intervention Description
Sodium bicarbonate 500 ml followed by 100 ml/hour for 5 hours combined with acetylcystein tablets for 2 days
Primary Outcome Measure Information:
Title
Prevention of contrast induced nephropathy in STEMI patients treated with primary PCI
Description
Rise in creatinine >25% from baseline to day 3
Time Frame
from baseline to day 3
Secondary Outcome Measure Information:
Title
Prevention of contrast induced nephropathy in STEMI patients treated with primary PCI
Description
Rise in creatinine >25% from baseline to day 30
Time Frame
from baseline to day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
STEMI patients treated with primary PCI
Exclusion Criteria:
Cardiogenic shock
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Thayssen, MD DMSci
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
24714489
Citation
Thayssen P, Lassen JF, Jensen SE, Hansen KN, Hansen HS, Christiansen EH, Junker A, Ravkilde J, Thuesen L, Veien KT, Jensen LO. Prevention of contrast-induced nephropathy with N-acetylcysteine or sodium bicarbonate in patients with ST-segment-myocardial infarction: a prospective, randomized, open-labeled trial. Circ Cardiovasc Interv. 2014 Apr;7(2):216-24. doi: 10.1161/CIRCINTERVENTIONS.113.000653. Epub 2014 Apr 8.
Results Reference
derived
Learn more about this trial
Prevention of Contrast-induced Nephropathy in Patients With Acute Myocardial Infarction
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