Fish oil Inhibition of Stenosis in Haemodialysis grafts study
| ISRCTN | ISRCTN15838383 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15838383 |
| Secondary identifying numbers | 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
Not provided at time of registration
Contact information
Dr Charmaine Lok
Scientific
Scientific
The Toronto General Hospital
11 East Wing - 216
200 Elizabeth Street
Toronto, ON
M5G 2C4
Canada
| Phone | +1 416 340 4140 |
|---|---|
| charmaine.lok@uhn.on.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | FISH |
| Study hypothesis | 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. |
| Condition | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Fish oil |
| Primary outcome measure | The proportion of PTFE grafts with loss of native patency within 12 months |
| Secondary outcome measures | 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 |
| Overall study start date | 01/01/2004 |
| Overall study end date | 01/07/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 232 |
| Participant inclusion criteria | 1. End stage renal disease haemodialysis patients who require a graft access 2. 18 and above years of age, either sex |
| Participant 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 |
| Recruitment start date | 01/01/2004 |
| Recruitment end date | 01/07/2009 |
Locations
Countries of recruitment
- Canada
Study participating centre
The Toronto General Hospital
Toronto, ON
M5G 2C4
Canada
M5G 2C4
Canada
Sponsor information
Canadian Institutes of Health Research (CIHR) (Canada)
Research organisation
Research organisation
Room 97
160 Elgin Street
Address locator: 4809A
Ottawa, ON
K1A OW9
Canada
| Phone | +1 888 603 4178 |
|---|---|
| info@cihr-irsc.gc.ca | |
| Website | http://www.cihr-irsc.gc.ca/ |
"ROR" |
https://ror.org/01gavpb45 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT 67812)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/11/2007 | Yes | No | |
| Results article | results | 02/05/2012 | Yes | No |
