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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-07-31

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.

Conditions

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Renal Failure, Chronic

Keywords

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Renal failure, chronic Death, sudden, cardiac Heart rate variability Tachycardia, ventricular Ventricular premature complexes Ventricular repolarization Eicosapentaenoic acid Docosahexaenoic acid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Interventions

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lipid emulsion with a high content of n-3 fatty acids

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Jeppe H Christensen, MD, DMSci

Role: PRINCIPAL_INVESTIGATOR

Aalborg Sygehus

Locations

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Department of Nephrology, Aalborg Hospital

Aalborg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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IVN3DIALYSE

Identifier Type: -

Identifier Source: org_study_id