Effekten af intravenøs infusion af n-3 polyumættede fedtsyrer på risikomarkører for pludselig hjertedød hos hæmodialysepatienter
- Conditions
- Chronic renal failure
- Registration Number
- EUCTR2005-002380-90-DK
- Lead Sponsor
- yremedicinsk afdeling, Aalborg Sygehus
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Patients with chronic renal failure undergoing haemodialysis treatment three times a week
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Allergy to fish or egg protein. Age < 18 yrs. Body Weight < 50 kg. Chronic supraventricular arrhythmias. Implanted pacemaker. Myocardial infarction or stroke within the past 6 months. Tendency to significant drop in bloodpressure during haemodialysis. Ongoing infection. Other serious illness. Fasting triglycerides > 3 mmol/L.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the effect of intravenous infusion of an emulsion rich on n-3 polyunsaturated fatty acids on heart rate variability and the occurence of arrhythmias in relation to haemodialysis treatment;Secondary Objective: To determine the content of n-3 polyunsaturated fatty acids in plasma and cell membranes before and after infusion;Primary end point(s): The effect on heart rate variability and arrhythmias
- Secondary Outcome Measures
Name Time Method