Clinical trial NCT03202212: Effect of Mixed On-line Hemodiafiltration on Circulating Markers of Inflammation and Vascular Dysfunction
Official title: Effect of Mixed On-line Hemodiafiltration on Circulating Markers of Inflammation and Vascular Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Kidney Failure
Dialysis Related Complication
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: RNA content of circulating particles
timeFrame: Study start (time 0) and study end (9 months)
Secondary outcomes:
measure: Circulating inflammatory markers
timeFrame: All the study timepoints: time 0 and 3, 6, 9 months
measure: RNA content of circulating particles
timeFrame: All the study timepoints: time 0 and 3, 6, 9 months
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Città della Salute e Della Scienza di Torino - Presidi CTO e Molinette
state: To
Study officials:
References: