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

Chronic Kidney Disease Requiring Chronic Dialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03190629
• Other study ID #: OL-HDF-63/16
• Status: Completed
• Phase: N/A
• First received: June 13, 2017
• Last updated: June 16, 2017
• Start date: April 1, 2012
• Est. completion date: March 31, 2013

Study information

• Verified date: June 2017
• Source: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 31, 2013
• Est. primary completion date: March 31, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease Requiring Chronic Dialysis
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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).
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pablo Molina

References & Publications (4)

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. Review. — View 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. — View 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;175:170-85. doi: 10.1159/000333636. Epub 2011 Dec 15. — View Citation

Maduell F, Navarro V, Rius A, Torregrosa E, Sánchez JJ, Saborit ML, Ferrero JA. [Improvement of nutritional status in patients with short daily on-line hemodiafiltration]. Nefrologia. 2004;24(1):60-6. Spanish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lean tissue mass in kilograms	Change from baseline to end of study in lean tissue mass in kilograms, measured quarterly throughout the 12-month intervention. Lean tissue mass was assessed by multi-frequency bioimpedance spectroscopy (Fresenius Medical Care) by experienced research staff blinded to all clinical and biochemical data of the patients. In order to control for potential variability and the effect of overhydration, all bioimpedance analyses were performed before a mid-week dialysis session.	Baseline, 4, 8, and 12 months.
Primary	Intracellular water in liters	Change from baseline to end of study in intracellular water in liters, measured quarterly throughout the 12-month intervention. Intracellular water was assessed by multi-frequency bioimpedance spectroscopy (Fresenius Medical Care) by experienced research staff blinded to all clinical and biochemical data of the patients. In order to control for potential variability and the effect of overhydration, all bioimpedance analyses were performed before a mid-week dialysis session.	Baseline, 4, 8, and 12 months.
Primary	Body cell mass in kilograms	Change from baseline to end of study in body cell mass in kilograms, measured quarterly throughout the 12-month intervention. Body cell mass was assessed by multi-frequency bioimpedance spectroscopy (Fresenius Medical Care) by experienced research staff blinded to all clinical and biochemical data of the patients. In order to control for potential variability and the effect of overhydration, all bioimpedance analyses were performed before a mid-week dialysis session.	Baseline, 4, 8, and 12 months.
Secondary	Serum prealbumin levels in milligrams per deciliter	Change from baseline to end of study in serum prealbumin concentration in milligrams per decilitre, measured quarterly throughout the 12-month intervention. Pre-dialytic blood samples were collected after insertion of the access needle, and the post-dialytic sample was drawn from the arterial needle after slowing the blood punt to 50 ml/min. Prealbumin was determined by nephelometry with the IMMAGE800 Immunochemistry System (Beckman Coulter, Galway, Ireland).	Baseline, 4, 8, and 12 months.