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

Chronic Kidney Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03202212
• Other study ID #: 0030959 CEI/568
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 8, 2017
• Last updated: June 27, 2017
• Start date: February 3, 2014
• Est. completion date: November 11, 2014

Study information

• Verified date: June 2017
• Source: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 11, 2014
• Est. primary completion date: February 10, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Failure
• Dialysis Related Complication
• Inflammation
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Procedure:
• mixed on-line hemodiafiltration
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
Standard high flux bicarbonate dialysis with polysulfone membrane, three sessions per week, four hours per session

Locations

Country	Name	City	State
Italy	Città della Salute e Della Scienza di Torino - Presidi CTO e Molinette	Torino	To

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Città della Salute e della Scienza di Torino

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RNA content of circulating particles	Quantitative micro-RNA changes in plasmatic exosomes/microvesicles assessed by quantitative real-time PCR	Study start (time 0) and study end (9 months)
Secondary	Circulating inflammatory markers	Quantitative changes in C-Reactive Protein, Neutrophil Gelatinase Associated Lipocalin, Interleukin-6, Ferritin	All the study timepoints: time 0 and 3, 6, 9 months
Secondary	RNA content of circulating particles	Quantitative micro-RNA changes in plasmatic exosomes/microvesicles assessed by quantitative real-time PCR	All the study timepoints: time 0 and 3, 6, 9 months