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OpenTrials
Completed

NCT Number: NCT01160627

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

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Key information

Conditions

Contrast Induced Nephropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital

Odense, 5000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • STEMI patients treated with primary PCI

Exclusion criteria

  • Cardiogenic shock

Treatment and study plan

hydration

Other

Saline hydration

acetylcysteine

Drug

Acetylcystein tablets for 2 days

Sodium bicarbonate

Drug

Sodium bicarbonate 500 ml followed by 100 ml/hour for 5 hours

Combined Acetylcystein and Sodium Bicarbonate

Drug

Sodium bicarbonate 500 ml followed by 100 ml/hour for 5 hours combined with acetylcystein tablets for 2 days

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 12, 2010
Registry last updated
Mar 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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