NCT00259025

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 29, 2005

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

August 11, 2008

Status Verified

April 1, 2008

Enrollment Period

10 months

First QC Date

November 25, 2005

Last Update Submit

August 8, 2008

Conditions

Renal Failure, Chronic

Keywords

Renal failure, chronicDeath, sudden, cardiacHeart rate variabilityTachycardia, ventricularVentricular premature complexesVentricular repolarizationEicosapentaenoic acidDocosahexaenoic acid

Outcome Measures

Primary Outcomes (1)

  • Heart rate variability

Secondary Outcomes (2)

  • Ventricular repolarization, ventricular arrhythmias

  • n-3 polyunsaturated fatty acids in plasma and cell membranes

Interventions

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

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 yrs
  • End-stage renal failure
  • Maintenance haemodialysis treatment \> 3 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nephrology, Aalborg Hospital

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Kidney Failure, ChronicDeath, Sudden, CardiacTachycardia, VentricularVentricular Premature Complexes

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart ArrestHeart DiseasesCardiovascular DiseasesDeath, SuddenDeathTachycardiaArrhythmias, CardiacCardiac Conduction System DiseaseCardiac Complexes, Premature

Study Officials

  • Jeppe H Christensen, MD, DMSci

    Aalborg Sygehus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 25, 2005

First Posted

November 29, 2005

Study Start

September 1, 2006

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

August 11, 2008

Record last verified: 2008-04

Locations

DK(1)