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Effekten af intravenøs infusion af n-3 polyumættede fedtsyrer på risikomarkører for pludselig hjertedød hos hæmodialysepatienter

Effekten af intravenøs infusion af n-3 polyumættede fedtsyrer på risikomarkører for pludselig hjertedød hos hæmodialysepatienter

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-002380-90-DK
Enrollment
70
Registered
2005-08-24
Start date
2005-09-26
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic renal failure

Interventions

Trade Name: Omegaven Product Name: Omegaven Pharmaceutical Form: Emulsion for infusion Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Intravenous use

Sponsors

Nyremedicinsk afdeling, Aalborg Sygehus
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Allergy to fish or egg protein. Age 3 mmol/L.

Design outcomes

Primary

MeasureTime frame
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

Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026