Analysis of CKRT Treatments With multiFlux Hemofilters Using RCA or Systemic Heparin Anticoagulation

Fresenius Medical Care Deutschland GmbH1 个研究点分布在 1 个国家目标入组 62 人开始时间: 2026年11月1日最近更新: 2026年9月4日

适应症

干预措施

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Fresenius Medical Care Deutschland GmbH
入组人数: 62
试验地点: 1
主要终点: Rate of clearance (Creatinine reduction in blood and effluent) as therapy efficacy at specified time points

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The goal of this observational study is to assess the performance of the multiFlux hemofilterwith regional or systemic anticoagulation during CKRT treatments. The multiFlux hemofilter is a single use device within the extracorporeal blood circuit during extracorporeal blood purification treatments for acute renal replacement therapies.

详细描述

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: 1 Year 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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