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
  Purpose

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 Intervention
Contrast Induced Nephropathy
Other: Hydration
Drug: Acetylcysteine
Drug: Sodium bicarbonate
Drug: Combined Acetylcystein and Sodium Bicarbonate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Contrast-induced Nephropathy in Patients With Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 720
Study Start Date: April 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • STEMI patients treated with primary PCI

Exclusion Criteria:

  • Cardiogenic shock
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Odense University Hospital

Additional 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
Study First Received: July 9, 2010
Last Updated: March 21, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by 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
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014