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Completed

NCT Number: NCT03202212

Effect of Mixed On-line Hemodiafiltration on Circulating Markers of Inflammation and Vascular Dysfunction

On line haemodiafiltration (OL-HDF) has been shown to improve intra-dialytic hemodynamics and cardiovascular outcomes. Several potential candidates of these beneficial effects have been explored. The aim of this study was to investigate the impact of mixed OL-HDF (mOL-HDF) on different circulating mediators of vascular dysfunction.

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Key information

Conditions

Chronic Kidney Failure Chronic Disease Dialysis Related Complication Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Città della Salute e Della Scienza di Torino - Presidi CTO e Molinette

Torino, To, 10126, Italy

About this study

This is an open label placebo-controlled randomized clinical trial to assess the effect of mixed OL-HDF (mOL-HDF) on different circulating mediators of vascular dysfunction.

Inclusion criteria

age > 18 yrs, hemodialytic treatment from at least 6 months (3 times for week), blood flow rate (Qb) ≥ 250 ml/min using arterovenous fistula (AVF) or permanent central venous catheter (CVC), blood creatinine clearance <5 ml/min, urine output<500 ml/die.

Exclusion criteria

neoplastic diseases, chronic autoimmune diseases, lack of consent, solid organ or bone marrow transplantation.

Safety Assessment: the use of mOL-HDF has been approved by the European Medicines Agency as routine hemodepurative technique for end stage renal disease patients. Patients were evaluated for adverse reaction at each dialysis section; investigators recorded intra and extra-dialytic adverse events.

Study Treatment, Dosage, and Route of Administration: Enrolled patients have been randomized in 2 groups: 15 patients continued high flux bicarbonate hemodialysis (BHD), whereas 15 patients switched to mixed on-line hemodiafiltration (mOL-HDF using FX 1000 CorDiax, Fresenius Medical Care, Bad Homburg, Germany) for 9 months.

Efficacy Assessments:

Main outcome variable: changes in RNA content of circulating exosome/microvesicles (at 9 months) Secondary outcomes: changes in circulating inflammatory markers (C-Reactive Protein, Neutrophil Gelatinase Associated Lipocalin, Interleukin-6, Ferritin) at 3-6 and 9 months. changes in RNA content of circulating microvesicles (at 3 and 6 months)

Study Duration: 9 months

Statistical Methods: Data have been analyzed according to an intention-to-treat approach. Statistical analysis was performed using the unpaired Student t -test, ANOVA, or Kruskal-Wallis test when appropriate. A two-sided value of p=0.05 was considered significant.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • hemodialytic treatment from at least 6 months (3 times for week), blood flow rate during dialysis session (Qb) ≥250 ml/min using arterovenous fistula (AVF) or permanent central venous catheter (CVC), blood creatinine clearance <5 ml/min, urine output <500 ml/die.

Exclusion criteria

  • neoplastic diseases, autoimmune diseases, solid organ or bone marrow transplantation

Treatment and study plan

mixed on-line hemodiafiltration

Procedure

This is a mixed hemodepurative technique exploiting diffusion and convection through a semi-permeable membrane. Dialysis solution is not only interfacing with blood through the membrane (as in bicarbonate hemodialysis) but it is also mixed with it with a pre- and a post- filter dilution. The same amount of fluid added to the bloodstream is then removed within the filter through an appropriate negative pressure in the dialysis solution compartment and thanks a high permeability membrane. Patients will be treated three sessions per week, four hours per session

High flux bicarbonate dialysis

Procedure

Standard high flux bicarbonate dialysis with polysulfone membrane, three sessions per week, four hours per session

Primary outcomes

  1. RNA content of circulating particles

    Time frame: Study start (time 0) and study end (9 months)

    Quantitative micro-RNA changes in plasmatic exosomes/microvesicles assessed by quantitative real-time PCR

Secondary outcomes

  1. Circulating inflammatory markers

    Time frame: All the study timepoints: time 0 and 3, 6, 9 months

    Quantitative changes in C-Reactive Protein, Neutrophil Gelatinase Associated Lipocalin, Interleukin-6, Ferritin

  2. RNA content of circulating particles

    Time frame: All the study timepoints: time 0 and 3, 6, 9 months

    Quantitative micro-RNA changes in plasmatic exosomes/microvesicles assessed by quantitative real-time PCR

Sponsors and collaborators

Lead sponsor

A.O.U. Città della Salute e della Scienza

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 28, 2017
Registry last updated
Jun 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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