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临床试验/NCT02863016
NCT02863016已完成不适用

tHe Effects of Postdilution Online Hemodiafiltration With AcEtate-free Citrate dialySis Fluid on Inflammation Markers in TUscan Prevalent Hemodialysis patientS: HEPHAESTUS Study

Ospedale Santa Maria Annunziata3 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2016年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
66
试验地点
3
主要终点
Inflammation

研究概览

简要总结

The aim of this study was to evaluate the effect and timing of action on the inflammatory state of a acetate-free containing citrate concentrate (Cit-, 1 mM Citrate) in online postidultion HDF with high volumes compared to traditional concentrated (Ac-, 3 mM of acetate ) in the medium term. In addition, the study will evaluate other parameters of efficiency dialysis, cardiovascular stability, the safety of the concentrate with regard to bone metabolism and vessel calcification in the medium term.

详细描述

The primary objective of this study was to evaluate if a hemodiafiltration with concentrated citrate (Cit-HDF) in 3 months can reduce the inflammation markers, evaluated by a Predialytic value of Beta2-microglobulin (B2m), CRP and IL6 compared to traditional concentrated acetic acid (Ac-HDF).

The secondary objectives of this study are to evaluate if Cit-HDF, compared to Ac-HDF, can have an effect in a period of 3 months on the following aspects:

  • the change weekly pre-dialysis values of other markers of oxidative stress (TAC, NF-kB);

  • the technical parameters of HDF treatment, such as convective volumes, and blood pressure in the circuit in the filter (TMP, pressure pre-filter);

  • the cardiovascular stability through blood pressure and heart rate before and after dialysis (SBP, DBP, HR) and number of intradialytic hypotension;

  • the parameters of safety as the variation of the values of the mobility Predialytic bone (PTH, alkaline phosphatase, fetuin-A), the variation of the values intradialytic biochemical impacted by citrate (total and ionized calcium, bicarbonate) and clotting time (aPTT);

  • the variation of calcifications observed by:

  • the expression of molecules that express the ability of calcification of muscle cells and endothelial cells in culture with plasma taken at the beginning of treatment

  • a measure of carotid intimal thickness and pulse vawe velocity by Eco Color Doppler (optional);

  • dialysis efficiency by varying pre-and post-dialysis (RR%) and Clearance average molecular weight solutes with small and medium (Phosphorus, Beta2 Micro, Myoglobin) and indices of dialysis adequacy of small molecules such as EKT / V based on the dialysance ion formula Watson (calculated automatically by the monitor to dialysis);

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • . Patients clinically stable.
  • HDF in renal replacement therapy for more than 1 month.
  • good functionality of the vascular blood flow that allows real at least 250 ml / min. and recirculation below 10%.

排除标准

  • Life expectancy <3 months.
  • With residual renal function> 500 ml / day.
  • Vascular access with CVC

结局指标

主要结局

Inflammation

时间窗: 3 months

Value of IL-6

次要结局

  • Dialytic dose(3 months)

研究者

发起方
Ospedale Santa Maria Annunziata
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesco Pizzarelli

Principal Investigator

Ospedale Santa Maria Annunziata

研究点 (3)

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