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

March 21, 2013 updated by: Lisette Okkels Jensen, Odense University Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

720

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • STEMI patients treated with primary PCI

Exclusion Criteria:

  • Cardiogenic shock

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from baseline to day 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from baseline to day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

July 9, 2010

First Submitted That Met QC Criteria

July 9, 2010

First Posted (Estimate)

July 12, 2010

Study Record Updates

Last Update Posted (Estimate)

March 22, 2013

Last Update Submitted That Met QC Criteria

March 21, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIN in STEMI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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