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

NCT03202212 | Completed Phase 1

• 1 other identifier: 0030959 CEI/568
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Failure; Dialysis Related Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Circulating inflammatory markers

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

• RNA content of circulating particles

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

Study Arms (2)

Mixed on-line hemodiafiltration

EXPERIMENTAL

Mixed on-line hemodiafiltration (mOL-HDF using FX 1000 CorDiax, Fresenius Medical Care, Bad Homburg, Germany), three sessions per week, four hours per session

Procedure: mixed on-line hemodiafiltration

High flux bicarbonate dialysis

ACTIVE COMPARATOR

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

Procedure: High flux bicarbonate dialysis

Interventions

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

Mixed on-line hemodiafiltration

High flux bicarbonate dialysis PROCEDURE

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

High flux bicarbonate dialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• A.O.U. Città della Salute e della Scienza: lead

Study Sites (1)

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

Torino, To, 10126, Italy

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator - Associate Professor of Nephrology

Model Details: 30 patients treated with a standard 3-time per week bicarbonate high-flux hemodialysis will be randomized 1:1 to continue the treatment or to be switched to mixed on-line hemodiafiltration for 9 months

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 28, 2017
• Study Start: February 3, 2014
• Primary Completion: February 10, 2014
• Study Completion: November 11, 2014
• Last Updated: June 29, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)