PISCES: Protection against Incidences of Serious Cardiovascular Events Study with daily fish oil supplementation in dialysis patients

Protection against Incidences of Serious Cardiovascular Events Study with daily fish oil supplementation in dialysis patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN00691795

Enrollment

1100

Registered

2013-11-05

Start date

2013-11-06

Completion date

Unknown

Last updated

2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incident and prevalent chronic dialysis patients with or without previous cardiovascular events Circulatory System

Interventions

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

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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)

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Australia, Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 7, 2026