Effect of Mixed On-line Hemodiafiltration on Circulating Markers of Inflammation and Vascular Dysfunction
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic Kidney Failure
- Sponsor
- A.O.U. Città della Salute e della Scienza
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- RNA content of circulating particles
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Vincenzo Cantaluppi
Principal investigator - Associate Professor of Nephrology
A.O.U. Città della Salute e della Scienza
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
Outcomes
Primary Outcomes
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
- 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)