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

Primary Purpose

Renal Failure, Chronic

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
lipid emulsion with a high content of n-3 fatty acids
Sponsored by
Aalborg University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Renal Failure, Chronic focused on measuring Renal failure, chronic, Death, sudden, cardiac, Heart rate variability, Tachycardia, ventricular, Ventricular premature complexes, Ventricular repolarization, Eicosapentaenoic acid, Docosahexaenoic acid

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Nephrology, Aalborg Hospital

Outcomes

Primary Outcome Measures

Heart rate variability

Secondary Outcome Measures

Ventricular repolarization, ventricular arrhythmias
n-3 polyunsaturated fatty acids in plasma and cell membranes

Full Information

First Posted
November 25, 2005
Last Updated
August 8, 2008
Sponsor
Aalborg University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00259025
Brief Title
Intravenous n-3 Fatty Acids and Sudden Cardiac Death in Hemodialysis Patients
Official Title
The Effect of Intravenous n-3 Polyunsaturated Fatty Acids on Risk Markers for Sudden Cardiac Death in Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Aalborg University Hospital

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure, Chronic
Keywords
Renal failure, chronic, Death, sudden, cardiac, Heart rate variability, Tachycardia, ventricular, Ventricular premature complexes, Ventricular repolarization, Eicosapentaenoic acid, Docosahexaenoic acid

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
lipid emulsion with a high content of n-3 fatty acids
Primary Outcome Measure Information:
Title
Heart rate variability
Secondary Outcome Measure Information:
Title
Ventricular repolarization, ventricular arrhythmias
Title
n-3 polyunsaturated fatty acids in plasma and cell membranes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeppe H Christensen, MD, DMSci
Organizational Affiliation
Aalborg Sygehus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nephrology, Aalborg Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark

12. IPD Sharing Statement

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

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