Intravenous n-3 Fatty Acids and Sudden Cardiac Death in Hemodialysis Patients

Study Overview
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Brief Summary
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The main purpose of this study is to investigate whether intravenous infusion of a lipid emulsion with a high content of n-3 polyunsaturated fatty acids can improve heart rate variability and ventricular repolarization and reduce ventricular arrhythmias in hemodialysis patients.

Detailed Description
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Cardiovascular disease is the most common cause of death in haemodialysis (HD)patients, and half of these deaths are due to sudden cardiac death caused by ventricular arrhythmias. HD patients have an attenuated heart rate variability (HRV) and a high frequency of ventricular arrhythmias, both of which are predictors of sudden cardiac death(SCD). n-3 polyunsaturated fatty acids (PUFA) improves HRV and reduces the risk of SCD. n-3 PUFAs are obtained from fatty fish and fish oil and are incorporated into cell membranes after long-term ingestion. However, it is not known if this incorporation is essential or merely serves as storage for n-3 free PUFAs to be release during for instance myocardial ischaemia. The study hypothesis is that intravenous infusion of a lipid emulsion with a high content of n-3 PUFAs will improve HRV and ventricular repolarization and reduce ventricular arrhythmias via an acute increase in free non-esterified n-3 PUFAs in plasma. In a randomized, placebo-controlled design a n-3 PUFA rich emulsion (or placebo) will be administered during hemodialysis treatment. The two study groups will be compared with respect to heart rate variability, ventricular repolarization parameters, ventricular ectopic beats and arrhythmias and the content of n-3 PUFA in plasma and cell membranes will be compared.

Official Title
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The Effect of Intravenous n-3 Polyunsaturated Fatty Acids on Risk Markers for Sudden Cardiac Death in Hemodialysis Patients

Conditions
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Renal Failure, Chronic

Intervention / Treatment
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* Drug: lipid emulsion with a high content of n-3 fatty acids


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 yrs End-stage renal failure Maintenance haemodialysis treatment > 3 months Exclusion Criteria: Allergy to fish or egg protein Body weight < 50 kgs Chronic supraventricular tachycardia Implanted pacemaker Myocardial infarction within 6 months PCI or CABG within 6 months Stroke or TIA within 6 months HbA1C > 10 % ALAT > 100 U/l Triglycerides > 3 mmol/l Ongoing infection Tendency to severe blood pressure drops during dialysis treatment Malignancy Psychiatric disorder Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: lipid emulsion with a high content of n-3 fatty acids|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventricular repolarization, ventricular arrhythmias |  |  | 
| n-3 polyunsaturated fatty acids in plasma and cell membranes |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal failure, chronic, Death, sudden, cardiac, Heart rate variability, Tachycardia, ventricular, Ventricular premature complexes, Ventricular repolarization, Eicosapentaenoic acid, Docosahexaenoic acid