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临床试验/NCT01396980
NCT01396980已完成不适用

Sublingual Microcirculatory Flow Measurements During Haemodialysis in Relation to Blood Volume Change

Medical Centre Leeuwarden1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2011年9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
8
试验地点
1
主要终点
Difference between sublingual microvascular flow index between 2 types of ultrafiltration

研究概览

简要总结

  • SDF is validated by measuring changes in microcirculation in sepsis patients with MOF (Boerma studies).
  • SDF is validated by measuring changes in microcirculation in stable chronic hemodialysis patients (NDT 2009 Bemelmans).
  • Ultrafiltration in stable chronic hemodialysis leads to a decrease in sublingual microcirculatory flow (NDT 2009 Bemelmans).
  • Trendelenburg position improves the sublingual microcirculatory flow at the end of hemodialysis treatment (NDT 2009 Bemelmans).
  • Hemodialysis with ultrafiltration leads to a significant reduction of myocardial perfusion and cardiac output (NDT 2009 Dasselaar)
  • Cardiac output measurement during dialysis is not practical.
  • BVM is a validated method for hypotension due to ultrafiltration to prevent the amount of ultrafiltration online change based on the measured haemoconcentration (ref Dasselaar et al NDT 2005).
  • BCM is a validated measurement to the dry weight in hemodialysis patients measured by a bioimpedance technique (NDT Passauer et al 2009).

详细描述

The search for an optimal method of ultrafiltration with minimal hypoperfusion of vital organs.

  • Stabile hemodialysis patients with dialysis dependancy for more than 3 months, with adequate access

  • Study duration 3 weeks

  • Number of hemodialysis treatment for purposes of study: 3

  • Timing hemodialysis treatments for Study session Monday or Tuesday after the weekend (randomized design in the sessions)

  • session a: 5 hours total duration: 4 hours HD without UF followed by 1 hour GUF

  • Session b: 4 hours total duration: 4 hours HD with UF

  • session c: 4 hours total duration: 4 hours HD with UF and BVM

  • UF is determined by actual target weight.

  • Measurements during sessions:

  • In each session in advance: blood pressure, pulse, weight, BCM, laboratory tests (Hb, Hct, Na, K, urea, creatinine, calcium, albumin, phosphate, nt-proBNP, troponin T, CRP)

  • During each session at t = 0, t = 1 hour, t =2 hours and t = 4 hours: SDF, blood pressure, pulse, UF at that time, UF rate at that time

  • End each session: blood pressure, pulse, weight, BCM, laboratory tests (Hb, Hct, Na, K, urea, creatinine, calcium, albumin, phosphate, nt-proBNP, troponin T, CRP)

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

  • dialysis patient
  • age > 18
  • informed consent

排除标准

  • no adequate access
  • instable hemodynamics

结局指标

主要结局

Difference between sublingual microvascular flow index between 2 types of ultrafiltration

时间窗: 3 weeks

次要结局

未报告次要终点

研究者

发起方
Medical Centre Leeuwarden
申办方类型
Other
责任方
Principal Investigator
主要研究者

E.C. Boerma

Dr

Medical Centre Leeuwarden

研究点 (1)

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