Fish oil Inhibition of Stenosis in Haemodialysis grafts study

ISRCTN	ISRCTN15838383
DOI	https://doi.org/10.1186/ISRCTN15838383
Protocol serial number	MCT 67812
Sponsor	Canadian Institutes of Health Research (CIHR) (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT 67812)

Submission date: 29/06/2004
Registration date: 22/07/2004
Last edited: 08/05/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Charmaine Lok
Scientific

The Toronto General Hospital
11 East Wing - 216
200 Elizabeth Street
Toronto, ON
M5G 2C4
Canada

Phone	+1 416 340 4140
Email	charmaine.lok@uhn.on.ca

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	FISH
Study objectives	Primary Question: Will haemodialysis patients who receive oral fish oil capsule supplementation versus placebo capsule supplementation have a lower proportion of PolyTetraFluoroEthylene (PTFE) grafts without thrombosis, radiological or surgical intervention within 12 months of creation?
Ethics approval(s)	Ethics approval received from local research ethics committees.
Health condition(s) or problem(s) studied	End Stage Renal Disease (ESRD)
Intervention	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. As of 25/10/2006, the anticipated study end date has been extended to July 2009. The previous end date of this trial was 01/07/2007.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Fish oil
Primary outcome measure(s)	The proportion of PTFE grafts with loss of native patency within 12 months
Key secondary outcome measure(s)	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
Completion date	01/07/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	232
Key inclusion criteria	1. End stage renal disease haemodialysis patients who require a graft access 2. 18 and above years of age, either sex
Key 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
Date of first enrolment	01/01/2004
Date of final enrolment	01/07/2009

Locations

Countries of recruitment

Canada

Study participating centre

The Toronto General Hospital

Toronto, ON
M5G 2C4
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	02/05/2012		Yes	No
Protocol article	protocol	01/11/2007		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes