Efficacy and Safety of Paediatric CVVHD Treatment With MultiFiltratePRO: A Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 43
- 试验地点
- 4
- 主要终点
- Effluent dose
研究概览
简要总结
This clinical study evaluates the performance of the MultifiltratePro in pediatric mode for Continuous Venovenous Hemodiafiltration (CVVHD) in children. Its primary aim is to assess the efficacy of the MultifiltratePro in paediatric mode, specifically in achieving at least 80% of the prescribed effluent dose within 72 hours. Additionally, the study focuses on the safety of this mode in a paediatric setting, closely monitoring for clinical adverse events, hemodynamic instability, and electrolyte imbalances. Paediatric patients with body weights between 8kg and 40kg will be treated with the MultifiltratePro for a period of up to 10 days, with the treatment duration and approach being tailored to the severity of each patient's condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paediatric Patients:
- •Informed consent signed and dated by legal representative and investigator/ authorized physician.
- •The minors have received the information referred to in Article 63(2) 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.
- •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:
- •Estimated life expectancy greater than 3 days
- •Children under 18 years
- •Body weight ≥8kg and <40kg
- •Patients with clinical indication for CVVHD
排除标准
- •Any conditions which could interfere with the patient's ability to comply with the study
- •Patient or legal representative is not able to give informed consent according to European Medical Device Regulation and corresponding national regulations
- •In case of female patients: pregnancy or lactation period
- •Participation in an interventional clinical study during the preceding 30 days
- •Previous participation in the same study
- •Study-specific:
- •Hypersensitivity to heparin or known history of heparin induced thrombocytopenia (HIT Type II)
- •Uncontrolled bleeding and coagulation disorders
- •Decision to limit therapeutic interventions
- •Inability to establish the required vascular access
研究组 & 干预措施
CVVHD treatment in paediatric mode with multiFiltratePRO
Treatment of acute kidney injury paediatric patients with continuous veno-venous haemodiafiltration (CVVHD) in paediatric mode with multiFiltratePRO
干预措施: CVVHD treatment in paediatric mode with multiFiltratePRO (Device)
结局指标
主要结局
Effluent dose
时间窗: 0 hours and 72 hours after start of treatment
Performance parameters of the paediatric treatment mode of multiFiltratePRO based on the effluent dose (prescribed vs achieved effluent dose) at 72 hours (at least 80% of the machine prescribed dose) are analysed
次要结局
未报告次要终点