Fish oil Inhibition of Stenosis in Haemodialysis grafts study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15838383

Enrollment

232

Registered

2004-07-22

Start date

2004-01-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

End Stage Renal Disease (ESRD) Urological and Genital Diseases Renal disease

Interventions

Oral supplementation with four x 1 g fish oil capsules versus placebo capsule supplementation. In addition, standard guideline recommended care of haemodialysis grafts will continue to be followed. A

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. End stage renal disease haemodialysis patients who require a graft access 2. 18 and above years of age, either sex

Exclusion criteria

Exclusion criteria: 1. Acute renal failure, likely to be reversible with recovery of renal function 2. Surgical revision of a previous access e.g. a jump graft (i.e. must be a new PTFE graft) 3. Pregnancy 4. Active malignancy 5. Active major bleed within one month of enrolment (see below for definition of major bleed) 6. Malignant hypertension 7. Receiving more than two anti-platelet agents or anticoagulants i.e. use of Acetylsalicylic Acid (ASA) and coumadin is not an exclusion 8. Life expectancy less than six months 9. PTFE grafts that fail prior to and including post-operative day seven 10. Involvement in another graft trial 11. Current fish oil ingestion at the time of randomisation 12. Any known allergy to fish or fish products

Design outcomes

Primary

Measure	Time frame
The proportion of PTFE grafts with loss of native patency within 12 months	—

Secondary

Measure	Time frame
Secondary Endpoints: 1. The average change in Low-Density Lipoprotein (LDL) and fasting triglyceride from baseline to six months 2. The average difference in levels of Reactive Oxygen Species (ROS) (Malondialdehyde (MDA) and 3-nitrotyrosine) and C-reactive protein at baseline and six months 3. The fatty acid composition of total serum pholspholipids at baseline and six months Tertiary endpoints (within 12 months): Will provide information on the long term efficacy of fish oil on graft functioning and explore some of the other potential risks and benefits associated with fish oil consumption, such as its effect on bleeding and blood pressure. Rates and proportions will both be evaluated whenever possible to allow for comparison with the literature: 1. Total rate and proportion of: 1.1. Thrombosis 1.2. Radiological or surgical interventions 2. The time to: 2.1. First thrombosis 2.2. First angioplasty 3. The primary and cumulative patencies 4. The incidence of primary failure 5. Total rate and proportion of minor and major bleeding episodes. A minor bleeding episode is on that requires compression of the bleeding vessel for more than 30 minutes for it to cease without other intervention. A major bleeding episode is defined as one that requires either: 5.1. Blood transfusion 5.2. Correction using other blood products such as fresh frozen plasma 5.3. Admission into hospital to manage the bleeding episode 5.4. Admission into hospital due to complications of the bleeding episode 6. Average change in blood pressure and the number of Blood Pressure (BP) medications from baseline to six months and 12 months. BP will be taken post-dialysis in the sitting position, on three separate occasions in a week and then averaged, during the time points indicated 7. Rate and proportion of cardiac events: 7.1. Myocardial infarction 7.2. Congestive heart failure requiring hospitalisation 7.3. Cardiac related mortality 8. All cause mortality	—

Measure

Time frame

Secondary Endpoints: 1. The average change in Low-Density Lipoprotein (LDL) and fasting triglyceride from baseline to six months 2. The average difference in levels of Reactive Oxygen Species (ROS) (Malondialdehyde (MDA) and 3-nitrotyrosine) and C-reactive protein at baseline and six months 3. The fatty acid composition of total serum pholspholipids at baseline and six months Tertiary endpoints (within 12 months): Will provide information on the long term efficacy of fish oil on graft functioning and explore some of the other potential risks and benefits associated with fish oil consumption, such as its effect on bleeding and blood pressure. Rates and proportions will both be evaluated whenever possible to allow for comparison with the literature: 1. Total rate and proportion of: 1.1. Thrombosis 1.2. Radiological or surgical interventions 2. The time to: 2.1. First thrombosis 2.2. First angioplasty 3. The primary and cumulative patencies 4. The incidence of primary failure 5. Total rate and proportion of minor and major bleeding episodes. A minor bleeding episode is on that requires compression of the bleeding vessel for more than 30 minutes for it to cease without other intervention. A major bleeding episode is defined as one that requires either: 5.1. Blood transfusion 5.2. Correction using other blood products such as fresh frozen plasma 5.3. Admission into hospital to manage the bleeding episode 5.4. Admission into hospital due to complications of the bleeding episode 6. Average change in blood pressure and the number of Blood Pressure (BP) medications from baseline to six months and 12 months. BP will be taken post-dialysis in the sitting position, on three separate occasions in a week and then averaged, during the time points indicated 7. Rate and proportion of cardiac events: 7.1. Myocardial infarction 7.2. Congestive heart failure requiring hospitalisation 7.3. Cardiac related mortality 8. All cause mortality

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Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 26, 2026