ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01160627
Recruitment Status : Completed
First Posted : July 12, 2010
Last Update Posted : March 22, 2013
Sponsor:
Information provided by (Responsible Party):
Lisette Okkels Jensen, Odense University Hospital

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : April 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Prevention of contrast induced nephropathy in STEMI patients treated with primary PCI [ Time Frame: 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 [ Time Frame: from baseline to day 30 ]
    Rise in creatinine >25% from baseline to day 30



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • STEMI patients treated with primary PCI

Exclusion Criteria:

  • Cardiogenic shock

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01160627


Locations
Denmark
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Per Thayssen, MD DMSci Odense University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lisette Okkels Jensen, MD DMSci PhD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01160627     History of Changes
Other Study ID Numbers: CIN in STEMI
First Posted: July 12, 2010    Key Record Dates
Last Update Posted: March 22, 2013
Last Verified: March 2013

Keywords provided by Lisette Okkels Jensen, Odense University Hospital:
CIN STEMI

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Kidney Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Urologic Diseases
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes