Lok 2012.
Methods | Study design: multicenter, randomised, placebo‐controlled clinical trial | |
Participants | Country: 12 Canadian and 3 United States sites No. of participants randomised: 201 No. of participants who started the study intervention: 196 No. of participants who completed the trial: 164 (5 excluded prior to receiving treatment, 32 did not complete 12 months follow‐up) Age: 27 to 88 years Gender: M = 98, F = 98 Inclusion criteria: adults (≥ 18 years) who required a synthetic arteriovenous graft for chronic haemodialysis. The graft could be either a ‘first access’ or a ‘subsequent access’ after a previously failed access Exclusion criteria: reversible renal failure; active malignancy; pregnancy; malignant hypertension; active major bleed in the prior month; receiving more than 2 antiplatelet agents or anticoagulants; life expectancy less than 6 months; surgical revision of a previous access; arteriovenous graft that failed prior to and including postoperative day 7; ingestion of any form of fish oil at time of randomisation; allergy to fish or fish products; enrolment in another interventional study of arteriovenous grafts |
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Interventions | Treatment: four 1 gram fish oil capsules per day. Each capsule was MEG‐3 (Ocean Nutrition Canada Ltd), which contained 48% (400 mg/capsule) eicosapentaenoic acid (EPA) and 25% (200 mg/capsule) docosahexaenoic acid (DHA) Control: 4 placebo capsules per day containing 1% peppermint‐flavoured corn oil Duration: 12 months |
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Outcomes | Primary: proportion with loss of native patency within 12 months Secondary: rate and proportion of graft thrombosis, proportion with radiological or surgical intervention, cumulative graft patency, cardiovascular outcomes |
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Notes | Synthetic arteriovenous grafts Premature termination due to slow recruitment and lack of additional funds decreased study power from 80% to 74% |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Concealed allocation by central independent randomisation facility with stratification by site and first access or subsequent access |
Allocation concealment (selection bias) | Low risk | No pre‐allocation bias |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Stated that participants, study coordinators, care‐givers and site pharmacists were blinded to treatment allocation |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessment undertaken by an independent assessor who was blinded to treatment allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Five participants excluded after randomisation, but before treatment initiated. All participants were included in the primary analysis, even if they didn't complete follow‐up |
Selective reporting (reporting bias) | Low risk | Pre‐study protocol available |
Other bias | Low risk | Nil obvious |