Plain English Summary
Background and study aims
In North America, more than 450,000 people with kidney failure require dialysis. Cardiovascular (CV), (heart-related) events are the main causes of illness and death. However, there are no consistently proven medical therapies to reduce serious CV events. Fish oil may improve healing which might benefit the CV system. Our overall goal is to study the effect of fish oil in reducing CV events in dialysis patients.
Who can participate?
We aim to globally enroll about 5000 men and women aged over 18 years from participating dialysis centers.
What does the study involve?
Eligible participants will be randomly assigned to receive fish oil (four capsules per day) or placebo (dummy) supplementation. For the duration of the study they will be followed closely to see if they have any effect.
What are the possible benefits and risks of participating?
There are no known risks involved in participating in this study. New knowledge gained from the results of this study could impact the care given to dialysis patients immediately. If fish oil is found to reduce serious CV events it will significantly improve patient health and may reduce CV-event-related hospitalizations.
Where is the study run from?
This study is centrally led by Dr Charmaine Lok at The University Health Network through the Toronto General Research Institute in Toronto, Ontario, Canada and jointly coordinated by the Applied Health Research Centre (AHRC),Toronto, Ontario, Canada.
When is study starting and how long is it expected to run for?
Patients will be recruited over a 3-year period. All participants will be followed for a minimum of 3 years. The entire study is expected to run for 6 years starting from November 2013.
Who is funding the study?
This study is funded by the Toronto General Research Institute (TGRI) (Canada).
Who is the main contact?
Dr Charmaine Lok
pisces88rct@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Charmaine Lok
ORCID ID
Contact details
Toronto General Hospital
200 Elizabeth Street
8NU-844
Toronto
Ontario
M5G 2C4
Canada
charmaine.lok@uhn.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Protection against Incidences of Serious Cardiovascular Events Study: daily fish oil supplementation in dialysis patients
Acronym
PISCES
Study hypothesis
Given the exceedingly high risk of cardiovascular disease and sudden cardiac death in hemodialysis patients and the promising preliminary data on cardiovascular events from our previous FISH study, PISCES will confirm the effects of fish oil on reducing cardiovascular (CV) events in this patient population.
Ethics approval
University Health Network Researchs Ethics Board; 14/06/2013; REB Reference Number: 12-5769-B
Study design
Multicentre blinded (participants, study personnel, healthcare providers, outcome adjudicators), randomised placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Incident and prevalent chronic dialysis patients with or without previous cardiovascular events
Intervention
Participants will be randomised to receive either four capsules/day of a fish oil product called 40/20EE 1000 mg capsules (Ocean Nutrition Ltd-DSM), or matching inactive placebo (identical size, shape, colour, consistency, odour and taste). Study capsules will be steam deodorized and flavoured to ensure blinding of the intervention.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
The primary outcome is a serious CV event. A serious CV event is a composite outcome of CV death and non-fatal CVD events.
1. CV death: sudden cardiac death, fatal myocardial infarction (MI) or fatal stroke
2. Non-fatal CV events: non-fatal MI, non-fatal stroke, peripheral vascular disease (PVD) requiring amputation.
The primary outcome will be measured as time to first event and as a rate (e.g. number of events per unit time).
Secondary outcome measures
1. A composite outcome that includes all-cause mortality and the non-fatal CV events from the primary outcome
2. Individual components of the primary composite outcome
3. Heart failure (HF) requiring hospitalisation and/or intubation
4. All CV-related hospitalisations and interventions
5. All-cause mortality
These will be measured as time to first event and as a rate (e.g. number of events per unit time). Also, BP measurements (pre and post HD), ECGs and blood for n-3 polyunsaturated fatty acids (PUFA) levels will be obtained at pre-determined intervals for the trial duration. N-3 PUFA levels will help determine both compliance with study intervention and associations between blood levels of n-3 PUFA and study outcomes. Data will be collected for quality of life and economic analysis.
Overall trial start date
01/11/2013
Overall trial end date
01/11/2019
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adult (age >18 years) men and women with end-stage kidney disease (ESKD) who require chronic hemodialysis (HD) 3 or 4 times/week of duration 5 hours/session or less
2. Clinically stable (no hospitalization or emergency room [ER] visit 1 month before enrolment)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
4898
Participant exclusion criteria
1. Reversible, acute renal failure, likely with recovery of renal function
2. Pregnancy
3. Active malignancy
4. Active major bleed within 1 month of enrolment
5. Blood pressure (BP) higher than 180/120 (malignant level)
6. Receiving more than two antiplatelet agents or anticoagulants i.e. use of ASA and coumadin is not an exclusion
7. Life expectancy of less than 6 months (i.e. palliative dialysis patients)
8. Implanted implantable cardioverter-defibrillators (ICD) or planned ICD placement within the year
9. Involvement in another drug trial
10. Current fish oil ingestion at the time of randomization
11. Any known allergy to fish or fish products
12. Unable to provide written informed consent (self or legal representative)
Recruitment start date
01/11/2013
Recruitment end date
01/11/2019
Locations
Countries of recruitment
Australia, United Kingdom, United States of America
Trial participating centre
Toronto General Hospital
Toronto, Ontario
M5G 2C4
Canada
Funders
Funder type
Research organisation
Funder name
Toronto General Research Institute (TGRI) (Canada) - University Health Network - Chronic Kidney Disease Outcomes Research Fund
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary