Condition category
Circulatory System
Date applied
03/10/2013
Date assigned
05/11/2013
Last edited
12/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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 1100 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

When is study starting and how long is it expected to run for?
Patients will be recruited over a 5-year period. All participants will be followed for a minimum of 3.5 years. The entire study is expected to run for 10 years starting from November 2013.

Who is funding the study?
1. Heart and Stroke Foundation of Canada
2. Peter Munk Innovation Fund
3. Chronic Kidney Disease Outcomes Research Fund via private donation (Alexander Epstein)
4. Kidney CARE Network International
5. National Health and Medical Research Council (NHMRC) (Australia)

Who is the main contact?
Dr Charmaine Lok
pisces88rct@gmail.com

Trial website

http://piscesrct.org

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 with 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 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 measure

Current primary outcome measures as of 05/08/2020:
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 rate of CV events (e.g. number of events per unit time).

Previous primary outcome measures as of 05/08/2020:
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

Current secondary outcome measures as of 05/08/2020:
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 rate (e.g. number of events per unit time). and time to first event 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.

Previous 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

31/12/2022

Reason abandoned (if study stopped)

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

1100

Total final enrolment

1310

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, Canada

Trial participating centre

Toronto General Hospital
Toronto, Ontario
M5G 2C4
Canada

Sponsor information

Organisation

Toronto General Research Institute

Sponsor details

c/o Dr. Charmaine Lok
200 Elizabeth Street
8NU-844
Toronto
Ontario
M5G 2C4
Canada

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Heart and Stroke Foundation of Canada

Alternative name(s)

Heart and Stroke Foundation, Heart & Stroke Foundation of Canada, Heart & Stroke, Fondation des maladies du coeur et de l’avc, Fondation des Maladies du Cœur du Canada, Fondation des maladies du cœur et de l’AVC du Canada, HSFC, HSF

Funding Body Type

private sector organisation

Funding Body Subtype

International organizations

Location

Canada

Funder name

Peter Munk Innovation Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Chronic Kidney Disease Outcomes Research Fund via private donation (Alexander Epstein)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Kidney CARE Network International

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Health and Medical Research Council

Alternative name(s)

NHMRC

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Australia

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal is expected at the end of 2022.

IPD sharing statement
The datasets generated during and/or analysed during the current study may be available upon request based on institutional data sharing agreements.

Intention to publish date

31/12/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/08/2020: Total final enrolment number, publication and dissemination plan, and IPD sharing statement added. 05/08/2020: The following changes were made to the trial record: 1. The public title was changed from 'Protection against Incidences of Serious Cardiovascular Events Study (PISCES)' to 'PISCES: Protection against Incidences of Serious Cardiovascular Events Study with daily fish oil supplementation in dialysis patients'. 2. The scientific title was changed from 'Protection against Incidences of Serious Cardiovascular Events Study: daily fish oil supplementation in dialysis patients' to 'Protection against Incidences of Serious Cardiovascular Events Study with daily fish oil supplementation in dialysis patients'. 3. The primary and secondary outcome measures were updated. 4. The overall trial end date was changed from 01/11/2019 to 31/12/2022. 5. The target number of participants was changed from 4898 to 1100. 6. UK and USA removed from countries of recruitment. 7. Applied Health Research Centre (AHRC) (Canada) removed as a sponsor. 8. Toronto General Research Institute (TGRI) (Canada) - University Health Network - Chronic Kidney Disease Outcomes Research Fund were removed and Heart and Stroke Foundation of Canada, Peter Munk Innovation Fund, Chronic Kidney Disease Outcomes Research Fund via private donation (Alexander Epstein), Kidney CARE Network International, National Health and Medical Research Council (NHMRC) - Australia were added as funders. 9. The plain English summary was updated accordingly.