PISCES: Protection against Incidences of Serious Cardiovascular Events Study with daily fish oil supplementation in dialysis patients
| ISRCTN | ISRCTN00691795 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN00691795 |
- Submission date
- 03/10/2013
- Registration date
- 05/11/2013
- Last edited
- 11/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
Toronto General Hospital
200 Elizabeth Street
8NU-844
Toronto, Ontario
M5G 2C4
Canada
| charmaine.lok@uhn.ca |
Study information
| 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 |
| Study setting(s) | Home, Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Protection against Incidences of Serious Cardiovascular Events Study with daily fish oil supplementation in dialysis patients |
| Study acronym | PISCES |
| Study objectives | 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(s) | Approved 14/06/2013, University Health Network Researchs Ethics Board, ref: 12-5769-B |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/11/2013 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1100 |
| Total final enrolment | 1310 |
| Key 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) |
| Key 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) |
| Date of first enrolment | 06/11/2013 |
| Date of final enrolment | 01/11/2019 |
Locations
Countries of recruitment
- Australia
- Canada
Study participating centre
M5G 2C4
Canada
Sponsor information
Research organisation
c/o Dr. Charmaine Lok
200 Elizabeth Street
8NU-844
Toronto, Ontario
M5G 2C4
Canada
"ROR" |
https://ror.org/042xt5161 |
|---|
Funders
Funder type
Research organisation
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Heart and Stroke Foundation, Heart & Stroke Foundation of Canada, Heart & Stroke, Fondation des maladies du cœur et de l'AVC, Fondation des Maladies du Cœur du Canada, Fondation des maladies du cœur et de l'AVC du Canada, HSFC, HSF
- Location
- Canada
No information available
No information available
No information available
Government organisation / National government
- Alternative name(s)
- NHMRC
- Location
- Australia
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study may be available upon request based on institutional data sharing agreements. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 10/01/2024 | 11/01/2024 | Yes | No |
Editorial Notes
11/01/2024: Publication reference added.
03/02/2023: The recruitment start date has been changed from 01/11/2013 to 06/11/2013.
23/01/2023: The following changes have been made:
1. The overall trial end date has been changed from 31/12/2022 to 31/12/2023.
2. The intention to publish date has been changed from 31/12/2022 to 31/12/2024.
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.
