Modulation of Inflammation by Medium Cut Off Membranes (MCO-IF)
Medium-term Modulation of the Inflammatory Profile by Medium-cut Off Membranes in Patients With End Stage Renal Disease
研究概览
详细说明
Cardiovascular events and sepsis remain the leading causes of mortality in patients on maintenance hemodialysis. Thus expectancy of life for these patients is comparable to the prognosis of metastasized cancer. So far the exact mechanisms causing excess mortality in hemodialysis patients remain elusive, but chronic inflammation seems to play a central role in the pathogenesis of cardiovascular disease in HD patients.
Keeping this in mind the Theranova medium-cut off membrane, with its ability to clear middle molecules (0,5-50 kDa), seems suitable to further improve clearance of inflammatory mediators as the non-protein bound inflammatory mediators lie within the cut off range of this membrane. The investigators designed this study to get information on the changes in the inflammatory milieu in dialysis patients when using medium-cut off membranes which are know to significantly reduce cytokines compared to standard high-flux dialyzers.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Bavaria
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München、Bavaria、德国、81675
- 招聘中
- Department of nephrology, Klinikum rechts der Isar
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接触：
- Christoph Schmaderer, M.D.
- 电话号码：6701 0049-89-4140
- 邮箱：christoph.schmaderer@lrz.tum.de
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接触：
- Georg Lorenz, M.D.
- 电话号码：6704 0049-89-4140
- 邮箱：georg.lorenz@googlemail.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- time since initiation of dialysis > 3 months
- age > 18 years
Exclusion Criteria:
- time since initiation of dialysis < 3 months
- age < 18 years
- ongoing acute or chronic infection/malignoma, because this will interfere with inflammatory baseline values
- major surgery less than 2 weeks before inclusion in the study
- pregnancy
- mental illness
- lack of written and informed consent
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：MCO Dialysis
Theranova Dialyzer
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Hemodialysis
其他名称：
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有源比较器：Standard High Flux Dialysis
Standard High Flux Dialyzer
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Hemodialysis
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in inflammation
大体时间：240 days (cross-over design, multiple measurements)
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change of inflammatory score (inflammatory score is derived from multiple biomarkers)
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240 days (cross-over design, multiple measurements)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in calcification status
大体时间：240 days (cross-over design, multiple measurements)
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calcification score derived from several pro- and anticalcifying biomarkers
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240 days (cross-over design, multiple measurements)
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change in calcification propensity
大体时间：240 days (cross-over design, multiple measurements)
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this values measures the resistence of serum to a calcification stimulus
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240 days (cross-over design, multiple measurements)
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合作者和调查者
调查人员
- 首席研究员：Christoph Schmaderer, MD、attending Department of Nephrology, Klinikum rechts der Isar
出版物和有用的链接
一般刊物
- Ronco C, La Manna G. Expanded Hemodialysis: A New Therapy for a New Class of Membranes. Contrib Nephrol. 2017;190:124-133. doi: 10.1159/000468959. Epub 2017 May 23.
- Zickler D, Schindler R, Willy K, Martus P, Pawlak M, Storr M, Hulko M, Boehler T, Glomb MA, Liehr K, Henning C, Templin M, Trojanowicz B, Ulrich C, Werner K, Fiedler R, Girndt M. Medium Cut-Off (MCO) Membranes Reduce Inflammation in Chronic Dialysis Patients-A Randomized Controlled Clinical Trial. PLoS One. 2017 Jan 13;12(1):e0169024. doi: 10.1371/journal.pone.0169024. eCollection 2017.
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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