Effect of fish oil supplementation on graft patency and cardiovascular events among patients with new synthetic arteriovenous hemodialysis grafts: a randomized controlled trial
Lok CE, Moist L, Hemmelgarn BR, Tonelli M, Vazquez MA, Dorval M, Oliver M, Donnelly S, Allon M, Stanley K, Fish Oil Inhibition of Stenosis in Hemodialysis Grafts (FISH) Study Group
JAMA · 101 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- Canadian Institutes of Health Research
- Gobierno
- National Institute of Diabetes and Digestive and Kidney Diseases
- Gobierno
- NIDDK NIH HHS
- Gobierno
- CIHR
- Subvenciones
- National Institute of Diabetes and Digestive and Kidney Diseases (5UO1 DK082240); National Institute of Diabetes and Digestive and Kidney Diseases (R01-DK085027); National Institute of Diabetes and Digestive and Kidney Diseases (U01DK082240); National Institute of Diabetes and Digestive and Kidney Diseases (K24 DK059818); National Institute of Diabetes and Digestive and Kidney Diseases (R34 DK094115); National Institute of Diabetes and Digestive and Kidney Diseases (K24-DK59818-01)
Según 4 financiadores declarados.
Publicación
- Publicado
- 2012-05-01 · JAMA · vol. 307 · número 17 · pág. 1809
- Editorial
- American Medical Association
- Citado
- 146 citas · más que el 100% de estudios similares · 29.9× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 60 trabajos
- Acceso
- Acceso abierto (copia en repositorio)
- Áreas de investigación
- Central Venous Catheters and Hemodialysis · Fatty Acid Research and Health · Dialysis and Renal Disease Management
- Palabras clave
- fish oil supplementation, graft patency, graft thrombosis, graft stenosis, graft failure, cardiovascular events, chronic kidney disease, vascular access, omega-3 fatty acids, cardiovascular event-free survival, end-stage renal disease, eicosapentaenoic acid, docosahexaenoic acid
- MeSH
- humans, kidney failure, chronic, cardiovascular diseases, thrombosis, constriction, pathologic, graft occlusion, vascular, fish oils, renal dialysis, administration, oral, double-blind method, vascular patency, dietary supplements, adult, aged, aged, 80 and over, middle aged, female, male
1 autor
- Charmaine E. Lok🇨🇦 · autor de correspondenciaUniversity of Toronto; Toronto General Hospital
Resumen
El texto original del estudio, en el idioma en que se publicó.
Context
Synthetic arteriovenous grafts, an important option for hemodialysis vascular access, are prone to recurrent stenosis and thrombosis. Supplementation with fish oils has theoretical appeal for preventing these outcomes.
Objective
To determine the effect of fish oil on synthetic hemodialysis graft patency and cardiovascular events.
Design, setting, and participants
The Fish Oil Inhibition of Stenosis in Hemodialysis Grafts (FISH) study, a randomized, double-blind, controlled clinical trial conducted at 15 North American dialysis centers from November 2003 through December 2010 and enrolling 201 adults with stage 5 chronic kidney disease (50% women, 63% white, 53% with diabetes), with follow-up for 12 months after graft creation.
Interventions
Participants were randomly allocated to receive fish oil capsules (four 1-g capsules/d) or matching placebo on day 7 after graft creation.
Main outcome measure
Proportion of participants experiencing graft thrombosis or radiological or surgical intervention during 12 months' follow-up.
Results
The risk of the primary outcome did not differ between fish oil and placebo recipients (48/99 [48%] vs 60/97 [62%], respectively; relative risk, 0.78 [95% CI, 0.60 to 1.03; P = .06]). However, the rate of graft failure was lower in the fish oil group (3.43 vs 5.95 per 1000 access-days; incidence rate ratio [IRR], 0.58 [95% CI, 0.44 to 0.75; P < .001]). In the fish oil group, there were half as many thromboses (1.71 vs 3.41 per 1000 access-days; IRR, 0.50 [95% CI, 0.35 to 0.72; P < .001]); fewer corrective interventions (2.89 vs 4.92 per 1000 access-days; IRR, 0.59 [95% CI, 0.44 to 0.78; P < .001]); improved cardiovascular event-free survival (hazard ratio, 0.43 [95% CI, 0.19 to 0.96; P = .04]); and lower mean systolic blood pressure (-3.61 vs 4.49 mm Hg; difference, -8.10 [95% CI, -15.4 to -0.85]; P = .01).
Conclusions
Among patients with new hemodialysis grafts, daily fish oil ingestion did not decrease the proportion of grafts with loss of native patency within 12 months. Although fish oil improved some relevant secondary outcomes such as graft patency, rates of thrombosis, and interventions, other potential benefits on cardiovascular events require confirmation in future studies.
Trial registration
isrctn.org Identifier: ISRCTN15838383.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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