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

Not Applicable

Completed

• Conditions: Incident and prevalent chronic dialysis patients with or without previous cardiovascular events; Circulatory System

• Registration Number: ISRCTN00691795
• Lead Sponsor: Toronto General Research Institute

Brief Summary

2024 Protocol article in https://doi.org/10.1136/bmjopen-2023-072239 (added 11/01/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-05
• Study Completion: 2023-12-31
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1310

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measures as of 05/08/2020:<br>The primary outcome is a serious CV event. A serious CV event is a composite outcome of CV death and non-fatal CVD events.<br>1. CV death: sudden cardiac death, fatal myocardial infarction (MI) or fatal stroke<br>2. Non-fatal CV events: non-fatal MI, non-fatal stroke, peripheral vascular disease (PVD) requiring amputation.<br>The primary outcome will be measured as rate of CV events (e.g. number of events per unit time). <br><br>Previous primary outcome measures as of 05/08/2020:<br>The primary outcome is a serious CV event. A serious CV event is a composite outcome of CV death and non-fatal CVD events.<br>1. CV death: sudden cardiac death, fatal myocardial infarction (MI) or fatal stroke<br>2. Non-fatal CV events: non-fatal MI, non-fatal stroke, peripheral vascular disease (PVD) requiring amputation.<br>The primary outcome will be measured as time to first event and as a rate (e.g. number of events per unit time).