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临床试验/NCT01067313
NCT01067313已完成2 期

Evaluation of Continuous Hemodialysis With an Enhanced Middle Molecule Clearance Membrane in Intensive Care

Fresenius Medical Care France2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2008年7月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
24
试验地点
2
主要终点
Clearance of Urea

研究概览

简要总结

This study aims to demonstrate equivalence in terms of molecule removal between continuous hemodialysis using an "enhanced middle molecule clearance" membrane(Ultraflux EMiC2) and continuous hemofiltration using a standard membrane (Ultraflux AV1000S) in ICU patients requiring continuous renal replacement therapy.

详细描述

In sepsis, the removal of middle molecular weight molecules such as cytokines (also called blood purification), has shown a great interest in intensive care during the last decades. Indeed, these cytokines are involved in the development of the multi-organ failure syndrome when patients are in septic shock. There is some evidence to suggest that extracorporeal therapies (hemofiltration-hemodialysis)are interesting tools to modulate the inflammatory response and to restore the immune homeostasis.

However, hemodialysis using "conventional" membranes does not allow the removal of middle molecules. Conversely, high-volume hemofiltration is an appropriate therapy but it has a lot of drawbacks due to the high ultrafiltration rates (removal of beneficial small molecules, technical and economical issues due to the use of large amounts of fluid replacement). Finally, high cut-off hemofiltration has been reported to be associated with significant albumin loss.

Therefore, continuous "enhanced middle molecule clearance" hemodialysis could be an interesting alternative, making possible the removal of these middle molecules without significant albumin loss and with some theoretical advantages (reduced cost due to the possibility to produce the dialysate from a water circuit, decreased nursing workload).

The aim of this study is to assess the clearances of different kind of molecules (small, middle and large) when continuous enhanced middle molecule clearance hemodialysis is applied to septic patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

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

  • Male or female aged over 18 years.
  • ICU patients with septic shock and AKI requiring continuous renal replacement.
  • Patient able to agree to be enrolled in the study with informed consent. If the patient can not provide consent, only the consent of family members will be sought if they are present and, to default, the opinion of trustworthy person under article L.1111-6 of the French Health Code. If there is no family present, or trustworthy person designated, the subject will not be included in the study.

排除标准

  • Pregnancy or lactation.
  • Participation in another research protocol.
  • People particularly vulnerable as defined in Articles L.1121-5, L.1121-6, L.1121-7, L.1121-8 et L.1122-1-2 of the French Health Code.

结局指标

主要结局

Clearance of Urea

时间窗: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours

Clearance of creatinine

时间窗: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours

Clearance of total protein

时间窗: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours

Clearance of albumin

时间窗: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours

Clearance of Beta 2-microglobulin

时间窗: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours

Free light chains kappa of Immunoglobulins

时间窗: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours

次要结局

  • Mean arterial pressure(Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours)
  • vasopressor requirement(Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours)
  • PaO2 / FiO2(Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours)
  • Heart rate(Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours)
  • Lactate level(Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours)

研究者

申办方类型
Industry

研究点 (2)

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