NCT03190629

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2013

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 19, 2017

Completed
Last Updated

June 19, 2017

Status Verified

June 1, 2017

Enrollment Period

12 months

First QC Date

June 13, 2017

Last Update Submit

June 16, 2017

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis

Keywords

body compositionbioimpedancehemodialysishemodiafiltrationnutritional statusprotein energy wasting

Outcome Measures

Primary Outcomes (3)

  • 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.

  • 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.

  • 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 Outcomes (1)

  • Serum prealbumin levels in milligrams per deciliter

    Baseline, 4, 8, and 12 months.

Study Arms (2)

High-flux hemodialysis

ACTIVE COMPARATOR

3 times per week

Device: High-flux hemodialysis

On line-hemodiafiltration

EXPERIMENTAL

3 times per week

Device: On line-hemodiafiltration

Interventions

High-flux hemodialysisDEVICE

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).

High-flux hemodialysis
On line-hemodiafiltrationDEVICE

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.

On line-hemodiafiltration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 22188699BACKGROUND

  • 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.

    PMID: 23343547BACKGROUND

  • 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.

    PMID: 19889872BACKGROUND

  • 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.

    PMID: 15083959BACKGROUND

  • 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.

    PMID: 29370428DERIVED

Study Officials

  • Pablo Molina, MD, PhD

    Department of Nephrology, Hospital Universitari Dr Peset, Department of Medicine, Universitat de València, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 13, 2017

First Posted

June 19, 2017

Study Start

April 1, 2012

Primary Completion

March 31, 2013

Study Completion

March 31, 2013

Last Updated

June 19, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share