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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lisette Okkels Jensen, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01160627
First received: July 9, 2010
Last updated: March 21, 2013
Last verified: March 2013

July 9, 2010
March 21, 2013
April 2010
March 2013   (final data collection date for primary outcome measure)
Prevention of contrast induced nephropathy in STEMI patients treated with primary PCI [ Time Frame: from baseline to day 3 ] [ Designated as safety issue: Yes ]
Rise in creatinine >25% from baseline to day 3
Same as current
Complete list of historical versions of study NCT01160627 on ClinicalTrials.gov Archive Site
Prevention of contrast induced nephropathy in STEMI patients treated with primary PCI [ Time Frame: from baseline to day 30 ] [ Designated as safety issue: Yes ]
Rise in creatinine >25% from baseline to day 30
Same as current
Not Provided
Not Provided
 
Prevention of Contrast-induced Nephropathy in Patients With Acute Myocardial Infarction
Prevention of Contrast-induced Nephropathy in Patients With Acute Myocardial Infarction

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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Contrast Induced Nephropathy
  • Other: Hydration
    Saline hydration
  • Drug: Acetylcysteine
    Acetylcystein tablets for 2 days
  • Drug: Sodium bicarbonate
    Sodium bicarbonate 500 ml followed by 100 ml/hour for 5 hours
  • 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: Standard treatment
    Hydration
    Intervention: Other: Hydration
  • Active Comparator: Combined Acetylcystein and Sodium Bicarbonat
    Intervention: Drug: Combined Acetylcystein and Sodium Bicarbonate
  • Active Comparator: Sodium Bicarbonate
    Intervention: Drug: Sodium bicarbonate
  • Active Comparator: Acetylcystein for 2 days
    Standard treatment + acetylcystein for 2 days
    Intervention: Drug: Acetylcysteine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
720
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • STEMI patients treated with primary PCI

Exclusion Criteria:

  • Cardiogenic shock
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01160627
CIN in STEMI
Yes
Lisette Okkels Jensen, Odense University Hospital
Odense University Hospital
Not Provided
Principal Investigator: Per Thayssen, MD DMSci Odense University Hospital
Odense University Hospital
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP