Condition category
Urological and Genital Diseases
Date applied
29/06/2004
Date assigned
22/07/2004
Last edited
08/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Charmaine Lok

ORCID ID

Contact details

The Toronto General Hospital
11 East Wing - 216
200 Elizabeth Street
Toronto
ON
M5G 2C4
Canada
+1 416 340 4140
charmaine.lok@uhn.on.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT 67812

Study information

Scientific title

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

Ethics approval received from local research ethics committees.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Specified

Drug names

Fish oil

Primary outcome measures

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 trial start date

01/01/2004

Overall trial end date

01/07/2009

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

232

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

Trial participating centre

The Toronto General Hospital
Toronto, ON
M5G 2C4
Canada

Sponsor information

Organisation

Canadian Institutes of Health Research (CIHR) (Canada)

Sponsor details

Room 97
160 Elgin Street
Address locator: 4809A
Ottawa
ON
K1A OW9
Canada
+1 888 603 4178
info@cihr-irsc.gc.ca

Sponsor type

Research organisation

Website

http://www.cihr-irsc.gc.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT 67812)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17848497
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22550196

Publication citations

  1. Protocol

    Lok CE, Allon M, Donnelly S, Dorval M, Hemmelgarn B, Moist L, Oliver MJ, Tonelli M, Stanley K, Design of the fish oil inhibition of stenosis in hemodialysis grafts (FISH) study., Clin Trials, 2007, 4, 4, 357-367, doi: 10.1177/1740774507081218.

  2. Results

    Lok CE, Moist L, Hemmelgarn BR, Tonelli M, Vazquez MA, Dorval M, Oliver M, Donnelly S, Allon M, Stanley K, , Effect of fish oil supplementation on graft patency and cardiovascular events among patients with new synthetic arteriovenous hemodialysis grafts: a randomized controlled trial., JAMA, 2012, 307, 17, 1809-1816, doi: 10.1001/jama.2012.3473.

Additional files

Editorial Notes