The Effect of On-line Hemodiafiltratrion on Nutritional Status and Body Composition
Primary Purpose
Chronic Kidney Disease Requiring Chronic Dialysis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High-flux hemodialysis
On line-hemodiafiltration
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease Requiring Chronic Dialysis focused on measuring body composition, bioimpedance, hemodialysis, hemodiafiltration, nutritional status, protein energy wasting
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
High-flux hemodialysis
On line-hemodiafiltration
Arm Description
3 times per week
3 times per week
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03190629
Brief Title
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
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
April 1, 2012 (Actual)
Primary Completion Date
March 31, 2013 (Actual)
Study Completion Date
March 31, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pablo Molina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease Requiring Chronic Dialysis
Keywords
body composition, bioimpedance, hemodialysis, hemodiafiltration, nutritional status, protein energy wasting
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High-flux hemodialysis
Arm Type
Active Comparator
Arm Description
3 times per week
Arm Title
On line-hemodiafiltration
Arm Type
Experimental
Arm Description
3 times per week
Intervention Type
Device
Intervention Name(s)
High-flux hemodialysis
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
On line-hemodiafiltration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lean tissue mass in kilograms
Description
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.
Time Frame
Baseline, 4, 8, and 12 months.
Title
Intracellular water in liters
Description
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.
Time Frame
Baseline, 4, 8, and 12 months.
Title
Body cell mass in kilograms
Description
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.
Time Frame
Baseline, 4, 8, and 12 months.
Secondary Outcome Measure Information:
Title
Serum prealbumin levels in milligrams per deciliter
Description
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).
Time Frame
Baseline, 4, 8, and 12 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo Molina, MD, PhD
Organizational Affiliation
Department of Nephrology, Hospital Universitari Dr Peset, Department of Medicine, Universitat de València, Spain
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22188699
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.
Results Reference
background
PubMed Identifier
23343547
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.
Results Reference
background
PubMed Identifier
19889872
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.
Results Reference
background
PubMed Identifier
15083959
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.
Results Reference
background
PubMed Identifier
29370428
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.
Results Reference
derived
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The Effect of On-line Hemodiafiltratrion on Nutritional Status and Body Composition
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