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临床试验/NCT02962700
NCT02962700Unknown不适用

Effects of Continuous Haemofiltration vs Intermittent Haemodialysis on Microcirculatory Parameters in Septic Shock

Military Hospital of Tunis2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
changes in the concentration of glucose (mmol/l) in the extracellular fluid of the skeletal muscle using a microdialysis probe inserted into the quadriceps femoris muscle.

研究概览

简要总结

The aim of the study was to investigate whether CVVH, in comparison to intermittent haemodialysis (IHD), is able to improve regional perfusion in septic shock patients studied by muscle microdialysis

详细描述

A prospective, randomized, clinical study ,including septic shock patients with acute renal failure, aged over 16 years. Patients were randomized to receive either CVVH or IHD for renal replacement therapy. Intermittent haemodialysis was carried out during the first 4 h at day 1 and day 2 of the study period. Systemic haemodynamics and interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained at baseline, 6, 12,18 and 24 hours after initiation of renal replacement by using muscle microdialysis.

研究设计

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

入排标准

年龄范围
16 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • septic shock

排除标准

  • 未提供

研究组 & 干预措施

IHD for 4 hours

Active Comparator

Intermittent haemodialysis was carried out during the first 4 h at day 1 and day 2 of the study period.

Interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained at baseline, 6, 12,18 and 24 hours after initiation of renal replacement by using muscle microdialysis.

干预措施: muscle microdialysis (Device)

CVVHF

Experimental

CVVHF for 48 h interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained at baseline, 6, 12,18 and 24 hours after initiation of renal replacement by using muscle microdialysis.

干预措施: muscle microdialysis (Device)

结局指标

主要结局

changes in the concentration of glucose (mmol/l) in the extracellular fluid of the skeletal muscle using a microdialysis probe inserted into the quadriceps femoris muscle.

时间窗: at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement

changes in the concentration of lactate (mmol/l) in the extracellular fluid of the skeletal muscle using a microdialysis probe inserted into the quadriceps femoris muscle

时间窗: at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement

changes in the concentration of pyruvate (µmol/l) in the extracellular fluid of the skeletal muscle using a microdialysis probe inserted into the quadriceps femoris muscle

时间窗: at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement

changes in the concentration of glycerol (µmol/l) in the extracellular fluid of the skeletal muscle using a microdialysis probe inserted into the quadriceps femoris muscle

时间窗: at baseline, 6, 12,18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement

次要结局

  • changes in mean arterial blood pressure(at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement)
  • changes in heart rate(at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement)
  • changes in vasopressor support doses(at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement)

研究者

发起方
Military Hospital of Tunis
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hajjej Zied

Doctor

Military Hospital of Tunis

研究点 (2)

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