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Chronic Kidney Disease Requiring Chronic DialysisNCT03190629

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

A study testing High-flux hemodialysis and On line-hemodiafiltration in people with Chronic Kidney Disease Requiring Chronic Dialysis, run by Pablo Molina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
High-flux hemodialysis and On line-hemodiafiltration
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
No sites listed yet
Study dates
1 Apr 2012to 31 Mar 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

About this study

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

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.

Read the 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.

Being tested
High-flux hemodialysis, On line-hemodiafiltration
Keywords
body composition, bioimpedance, hemodialysis, hemodiafiltration, nutritional status, protein energy wasting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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).

  • 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.

Study groups in NCT03190629
Study groupRoleWhat they receive
High-flux hemodialysisActive comparator3 times per week
Receives: Device: High-flux hemodialysis
On line-hemodiafiltrationExperimental3 times per week
Receives: Device: On line-hemodiafiltration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 4, 8, and 12 months.

  2. 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.

    Measured: Baseline, 4, 8, and 12 months.

  3. 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.

    Measured: Baseline, 4, 8, and 12 months.

Secondary outcomes (1)

  1. 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).

    Measured: Baseline, 4, 8, and 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2017
  2. Study start1 Apr 2012
  3. Primary completion31 Mar 2013
  4. Study completion31 Mar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03190629
Sponsor's protocol ID
OL-HDF-63/16
Status last verified
Jun 2017
First submitted
13 Jun 2017
Last updated
19 Jun 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22188699

  • 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.

    PubMed 23343547

  • 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.

    PubMed 19889872

  • 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.

    PubMed 15083959

  • 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.

    PubMed 29370428

Questions about this trial

What is this clinical trial studying?

A study testing High-flux hemodialysis and On line-hemodiafiltration in people with Chronic Kidney Disease Requiring Chronic Dialysis, run by Pablo Molina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lean tissue mass in kilograms (time frame: Baseline, 4, 8, and 12 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03190629, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2017.

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