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临床试验/NCT05439681
NCT05439681已完成不适用

Hs-Troponin T Kinetics in Patients Treated With MCO Membranes Compared to High-flux, Low-flux Membranes and HDF

Medical University of Graz1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2022年8月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
1
主要终点
Troponin T - relative - 1 hour

研究概览

简要总结

In this study, 24 prevalent hemodialysis patients will undergo four regular hemodialysis sessions during which four different treatments will be performed.

  • Treatment 1: MCO membrane (=medium cut off)
  • Treatment 2: low flux membrane
  • Treatment 3: high flux membrane
  • Treatment 4: HDF(=hemodiafiltration) treatment with high flux membrane

So far, there is no data on cardiac bioenzyme levels during hemodialysis on the MCO membrane, thus, a acute elevation during hemodialysis might be mitigated by increased clearance.

详细描述

Patients who are on hemodialysis will be included in this study. After obtaining informed consent, patients will be treated with four different hemodialysis sessions:

  • Treatment 1: MCO membrane (=medium cut off)
  • Treatment 2: low flux membrane
  • Treatment 3: high flux membrane
  • Treatment 4: HDF(=hemodiafiltration) treatment with high flux membrane The order of the treatment regimens with the different membranes will be randomized in four sequences (Williams design).

Sequence 1: MCO, low flux, HDF, high flux Sequence 2: low flux, high flux, MCO, HDF Sequence 3: high flux, HDF, low flux, MCO Sequence 4: HDF, MCO, high flux, low flux Dialysis treatment will be standardized according to our clinic standard. Dialysis fluid temperature will be set to 1.0°C below the patient's body temperature, which will be assessed by auricular thermometers, to achieve maximal hemodynamic stability. Dialysis fluid composition will be standardized to calcium of 1.25mmol/L, bicarbonate of 30mmol/L, and a variable potassium and sodium concentration, depending on the patients' plasma potassium and sodium concentration.

Ultrafiltration volume will be set according to the caretaking provider.

Membranes used in the study will be FX CorDiax 10, 800 (Fresenius Medical Care, Bad Homburg vor der Höhe, Germany) and Theranova 400 (Baxter, Deerfield, Illinois, USA). We will perform the analysis only in mid-week dialysis due to the following reasons: First, hemodynamic stability is most often compromised during the first treatment of the week, due to the need of large volumes of ultrafiltration and, second, because we assume that troponin T levels reach a steady state 48 hours after the last dialysis session.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • •minimum 18 years of age
  • •End stage kidney disease patient undergoing hemodialysis
  • •Written consent of the participant after being informed

排除标准

  • •No informed consent was obtained
  • •Pregnancy

研究组 & 干预措施

HDF - MCO - high flux - low flux

Experimental

干预措施: FX 10 (Device)

HDF - MCO - high flux - low flux

Experimental

干预措施: FX CorDiax 800 (Device)

HDF - MCO - high flux - low flux

Experimental

干预措施: HDF (Device)

HDF - MCO - high flux - low flux

Experimental

干预措施: Theranova 400 (Device)

MCO - low flux - high flux - HDF

Experimental

Patients who are on hemodialysis will be treated with four different hemodialysis sessions:

  • Treatment 1: MCO membrane
  • Treatment 2: low flux membrane
  • Treatment 3: high flux membrane
  • Treatment 4: HDF treatment with high flux membrane The order of the treatment regimens with the different membranes will be randomized.

干预措施: Theranova 400 (Device)

MCO - low flux - high flux - HDF

Experimental

Patients who are on hemodialysis will be treated with four different hemodialysis sessions:

  • Treatment 1: MCO membrane
  • Treatment 2: low flux membrane
  • Treatment 3: high flux membrane
  • Treatment 4: HDF treatment with high flux membrane The order of the treatment regimens with the different membranes will be randomized.

干预措施: FX 10 (Device)

MCO - low flux - high flux - HDF

Experimental

Patients who are on hemodialysis will be treated with four different hemodialysis sessions:

  • Treatment 1: MCO membrane
  • Treatment 2: low flux membrane
  • Treatment 3: high flux membrane
  • Treatment 4: HDF treatment with high flux membrane The order of the treatment regimens with the different membranes will be randomized.

干预措施: FX CorDiax 800 (Device)

MCO - low flux - high flux - HDF

Experimental

Patients who are on hemodialysis will be treated with four different hemodialysis sessions:

  • Treatment 1: MCO membrane
  • Treatment 2: low flux membrane
  • Treatment 3: high flux membrane
  • Treatment 4: HDF treatment with high flux membrane The order of the treatment regimens with the different membranes will be randomized.

干预措施: HDF (Device)

low flux - high flux - MCO - HDF

Experimental

干预措施: HDF (Device)

low flux - high flux - MCO - HDF

Experimental

干预措施: Theranova 400 (Device)

low flux - high flux - MCO - HDF

Experimental

干预措施: FX 10 (Device)

low flux - high flux - MCO - HDF

Experimental

干预措施: FX CorDiax 800 (Device)

high flux - HDF - low flux - MCO

Experimental

干预措施: Theranova 400 (Device)

high flux - HDF - low flux - MCO

Experimental

干预措施: FX 10 (Device)

high flux - HDF - low flux - MCO

Experimental

干预措施: FX CorDiax 800 (Device)

high flux - HDF - low flux - MCO

Experimental

干预措施: HDF (Device)

结局指标

主要结局

Troponin T - relative - 1 hour

时间窗: 1 hour after start of hemodialysis

Relative change from baseline (pre-treatment) to after 1 hour of hemodialysis in high sensitivity cardiac troponin T, assessed by Roche Elycsys Assay.

次要结局

  • Troponin I - relative - 1 hour and 4 hours(1 hour and 4 hours after start of hemodialysis)
  • Troponin I - absolute - 1 hour and 4 hours(1 hour and 4 hours after start of hemodialysis)
  • Troponin T - relative - 4 hours(4 hours after start of hemodialysis)
  • Troponin T - absolute - 1 hour and 4 hours(1 hour and 4 hours after start of hemodialysis)

研究者

发起方
Medical University of Graz
申办方类型
Other
责任方
Sponsor

研究点 (1)

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