NCT03190629

The Effect of On-line Hemodiafiltratrion on Nutritional Status and Body Composition

The Effect of On-line Hemodiafiltratrion on Nutritional Status and Body Composition: A Prospective, Controlled, Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Pablo Molina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Compared to conventional hemodialysis (HD), on-line hemodiafiltration (OL-HDF) achieves a more efficient removal of uremic toxins and reduces inflammation, which could favourably affect nutritional status. The aim of this study was to evaluate the 1-year effect of OL-HDF on nutritional status and body composition in prevalent HD patients.

Detailed description

Postdilution on-line hemodiafiltration (OL-HDF) is considered the most efficient renal replacement treatment modality. Compared with conventional hemodialysis (HD), OL-HDF enables a better removal of middle molecular weight uremic toxins by combining convective and diffusive clearance. Although higher convection volume exchange has been associated with an increased survival advantage for dialysis patients, the mechanisms by which OL-HDF may improve outcomes remain unknown. On the basis of improved toxin removal, a potential benefit of OL-HDF on nutritional status has been postulated. However, evidence on the effect of OL-HDF on nutritional status is scarce and at times conflicting. Some observational and interventional studies have suggested that OL-HDF is associated with improved nutritional parameters; others have found no effect; and one study even reported negative effects of OL-HDF on nutritional status. The majority of these observations come from cohort studies, non-controlled interventions and/or secondary analysis of controlled trials. Further, there are currently no data examining the plausible effect of postdilution OL-HDF on body composition. To clarify this important knowledge gap, this prospective, controlled, study evaluated the effects of high volume postdilution OL-HDF on nutritional status and body composition in prevalent HD patients.

Conditions

• Chronic Kidney Disease Requiring Chronic Dialysis

Interventions

Type	Name	Description
DEVICE	High-flux hemodialysis	Hemodialysis treatment thrice weekly with the high-flux FX-100 dialyzer (Fresenius Medical Care, Bad Homburg, Germany; membrane: Helixone®; surface: 2.2 m2; UF coefficient: 73 ml/h mm Hg; ß2-microglobulin-sieving coefficient: 0.8; albumin-sieving coefficient: 0.001), including a minimum target dialysis dose (Kt/Vurea) ≥1.2 and a session length of 3.0 to 6.0 h. Hemodialysis treatments were performed with the 5008 hemodialysis system (Fresenius Medical Care).
DEVICE	On line-hemodiafiltration	Post-dilution on line-hemodiafiltration treatment thrice weekly with the high-flux FX-100 dialyzer (Fresenius Medical Care, Bad Homburg, Germany; membrane: Helixone®; surface: 2.2 m2; UF coefficient: 73 ml/h mm Hg; ß2-microglobulin-sieving coefficient: 0.8; albumin-sieving coefficient: 0.001), including a minimum target dialysis dose (Kt/Vurea) ≥1.2 and a session length of 3.0 to 6.0 h. Post-dilution on line-hemodiafiltration treatments were performed with the 5008 hemodialysis system (Fresenius Medical Care), with automatic adjustment of the substitution fluid flow rate for maximising substitution volume while simultaneously avoiding haemoconcentration and filter clotting.

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-03-31
• Completion: 2013-03-31
• First posted: 2017-06-19
• Last updated: 2017-06-19