Clinical trial NCT03190629: The Effect of On-line Hemodiafiltratrion on Nutritional Status and Body Composition
Official title: The Effect of On-line Hemodiafiltratrion on Nutritional Status and Body Composition: A Prospective, Controlled, Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
Keywords: body composition
bioimpedance
hemodialysis
hemodiafiltration
nutritional status
protein energy wasting
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
First posted: 2017-06-19
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* being over 18 yr old; receiving stable high-flux hemodialysis treatment for at least 3 mo (Kt/Vurea ≥1.2 and hemodialysis performed 3.0 to 6.0 h, three times weekly), and agreed to give informed consent.

Exclusion Criteria:

* malabsorption syndrome; active malignant disease or other critical illnesses; or treated with steroids or antiandrogens.

Primary outcomes:
measure: Lean tissue mass in kilograms
timeFrame: Baseline, 4, 8, and 12 months.
measure: Intracellular water in liters
timeFrame: Baseline, 4, 8, and 12 months.
measure: Body cell mass in kilograms
timeFrame: Baseline, 4, 8, and 12 months.
Secondary outcomes:
measure: Serum prealbumin levels in milligrams per deciliter
timeFrame: Baseline, 4, 8, and 12 months.
Other outcomes:
Locations:
Study officials:
affiliation: Department of Nephrology, Hospital Universitari Dr Peset, Department of Medicine, Universitat de València, Spain
name: Pablo Molina, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gatti E, Ronco C. Seeking an optimal renal replacement therapy for the chronic kidney disease epidemic: the case for on-line hemodiafiltration. Contrib Nephrol. 2011;175:170-185. doi: 10.1159/000333636. Epub 2011 Dec 15.
citation: Canaud B, Bowry SK. Emerging clinical evidence on online hemodiafiltration: does volume of ultrafiltration matter? Blood Purif. 2013;35(1-3):55-62. doi: 10.1159/000345175. Epub 2013 Jan 22.
citation: Fischbach M, Terzic J, Menouer S, Dheu C, Seuge L, Zalosczic A. Daily on line haemodiafiltration promotes catch-up growth in children on chronic dialysis. Nephrol Dial Transplant. 2010 Mar;25(3):867-73. doi: 10.1093/ndt/gfp565. Epub 2009 Nov 4.
citation: Maduell F, Navarro V, Rius A, Torregrosa E, Sanchez JJ, Saborit ML, Ferrero JA. [Improvement of nutritional status in patients with short daily on-line hemodiafiltration]. Nefrologia. 2004;24(1):60-6. Spanish.
citation: Molina P, Vizcaino B, Molina MD, Beltran S, Gonzalez-Moya M, Mora A, Castro-Alonso C, Kanter J, Avila AI, Gorriz JL, Estan N, Pallardo LM, Fouque D, Carrero JJ. The effect of high-volume online haemodiafiltration on nutritional status and body composition: the ProtEin Stores prEservaTion (PESET) study. Nephrol Dial Transplant. 2018 Jul 1;33(7):1223-1235. doi: 10.1093/ndt/gfx342.