Analysis of Continuous Kidney Replacement Therapy (CKRT) Treatments With multiFlux Hemofilters Using Regional Citrate Anticoagulation (RCA) or Systemic Heparin Anticoagulation (RCA-Flux)
Analysis of CKRT Treatments With multiFlux Hemofilters Using RCA or Systemic Heparin Anticoagulation
研究概览
地位
干预/治疗
- 设备:multiFlux 160 hemofilter with regional heparin anticoagulation
- 设备:multiFlux 160 hemofilter with RCA with regional citrate anticoagulation
- 设备:multiFlux 130 hemofilter with regional heparin anticoagulation
- 设备:multiFlux 130 hemofilter with RCA with regional citrate anticoagulation
- 设备:multiFlux 60 hemofilter with regional heparin anticoagulation
- 设备:multiFlux 60 hemofilter with RCA with regional citrate anticoagulation
详细说明
Patients enrolled in this clinical investigation will be treated either with citrate anticoagulation in Continuous venovenous hemodialysis (CVVHD) or Continuous venovenous hemodiafiltration (CVVHDF) in post-dilution mode (RCA-post-CVVHDF) with RCA using 4% citrate with Ci-Ca dialysate (without gas barrier)) or with heparin in any of the possible CKRT modes (pre-, post- or pre-post CVVH, CVVHD, pre-, post- or pre-post CVVHDF) for up to 10 days based on investigator´s decision (data beyond 10 days will not be collected within the study) or until withdrawal of informed consent or death.
For the study, treatment data will be documented for a maximum of 10 days.
The selection of the filter size depends on the prescription of the attending physician. The body weight limitations as shall be considered:
Mutiflux 160 ≥ 40 kg, Multiflux 130 ≥ 30 kg, Multiflux 60 ≥ 8 kg
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Anja Derlet-Savoia, Dr.
- 电话号码:+49 6172 268 6648
- 邮箱:Anja.Derlet@freseniusmedicalcare.com
研究联系人备份
- 姓名:Celina Meyer
- 电话号码:+49 6172 268 6809
- 邮箱:celina.meyer@freseniusmedicalcare.com
学习地点
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Bavaria
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Munich、Bavaria、德国、81377
- Klinikum der Ludwig-Maximilians-Universität München (LMU Klinikum)
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接触:
- Christina Christina Scharf-Janßen, Dr. med.
- 电话号码:089-4400-84163
- 邮箱:christina.scharf-janssen@med.uni-muenchen.de
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
General:
Patients ≥ 18 years:
Informed consent signed and dated by the investigator; and
- if patient is able to give consent: by the study patient
- if patients unable to give consent: by the legal representative/spouse according to § 1358 BGB or
if an emergency situation is determined: by an independent consultant physician.
Pediatric Patients < 18 years:
- Informed consent signed and dated by legal representative and investigator/ authorized physician.
- The minors have received the information referred to in Article 63(2) Medical Device Regulation (MDR) in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children. If able, the minors have to sign the informed consent, too.
- The explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in Article 63(2) MDR to refuse participation in, or to withdraw from, the clinical investigation at any time, is respected by the investigator
Study specific:
- Body weight ≥ 8kg
- Acute Kidney Injury (AKI) with clinical indication for CKRT
- Clinically estimated life expectancy greater than 3 days
Exclusion Criteria:
- Any conditions which could interfere with the patient's ability to comply with the study
- Patient or legal representative or authorized physician during emergency situation is not able to give informed consent according to European Medical Device Regulation and corresponding national regulations
- Participation in a different interventional clinical study during the preceding 30 days
- Previous participation in the same study
- Uncontrolled bleeding and coagulation disorders
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
AKI patients
Patients with acute Kidney Injury (AKI) with clinical indication for CKRT
|
Extracorporeal blood purification with the multiFlux 160 hemofilter during continuous kidney replacement therapy with RCA systemic heparin anticoagulation for patients suffering from acute kidney injury (AKI)
Extracorporeal blood purification with the multiFlux 160 hemofilter during continuous kidney replacement therapy with RCA using 4% citrate with Ci-Ca dialysate (without gas barrier) for patients suffering from acute kidney injury (AKI)
Extracorporeal blood purification with the multiFlux 130 hemofilter during continuous kidney replacement therapy with RCA systemic heparin anticoagulation for patients suffering from acute kidney injury (AKI)
Extracorporeal blood purification with the multiFlux130 hemofilter during continuous kidney replacement therapy with RCA using 4% citrate with Ci-Ca dialysate (without gas barrier) for patients suffering from acute kidney injury (AKI)
Extracorporeal blood purification with the multiFlux 60 hemofilter during continuous kidney replacement therapy with RCA systemic heparin anticoagulation for patients suffering from acute kidney injury (AKI)
Extracorporeal blood purification with the multiFlux 60 hemofilter during continuous kidney replacement therapy with RCA using 4% citrate with Ci-Ca dialysate (without gas barrier) for patients suffering from acute kidney injury (AKI)
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Rate of clearance (Creatinine reduction in blood and effluent) as therapy efficacy at specified time points
大体时间:From enrollment up to 10 days
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From enrollment up to 10 days
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Assessment of potential electrolyte imbalances or acid base disturbances during RCA treatment
大体时间:From enrollment up to 10 days
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From enrollment up to 10 days
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合作者和调查者
调查人员
- 首席研究员:Christina Scharf-Janßen, PD Dr. med.、LMU University Hospital
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
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
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CKRT-AKI-04-EU
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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