NCT05315817终止不适用
Safety and Performance Evaluation of multiPlus Dialysate During CRRT
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Serum creatinine removal
研究概览
简要总结
Assessment of the performance of multiPlus dialysate based on the serum creatinine removal 6 hours (360 min) after start of continuous veno-venous haemodialysis/ haemodiafiltration [CVVHD(F)].
multiPlus is a phosphate-containing dialysis solution for the use in continuous renal replacement therapy (CRRT) during acute kidney injury (AKI).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent form by investigator and by
- •a) the study patient: if patient is able to consent
- •b) the legal representative: if patient is unable to consent:
- •c) an independent consultant: in case of emergency
- •if c) either legal representative or study patient, whichever can be done sooner, should be informed by the investigator as soon as possible. If the informed consent has been obtained by the legal representative (b or emergency scenario) informed consent to continue the participation in the clinical investigation shall be obtained from the subject as soon as he or she is capable of giving informed consent (According to the MDR - Article 68 - Clinical investigations in emergency situations)
- •Minimum age of 18 years
- •Ability to understand the nature and requirements of the study (if patient is conscious)
- •Study specific:
- •Body weight greater than 40 kg
- •Acute Kidney Injury (AKI) with clinical indication for CVVHD/CVVHDF
- •Vascular access allowing blood flow of min 50mL/min
- •Estimated life expectancy greater than 3 days
排除标准
- •Any conditions which could interfere with the patient's ability to comply with the study
- •In case of female patients: pregnancy (negative pregnancy test for women below 55 years) or lactation period
- •Participation in an interventional clinical study during the preceding 30 days
- •Previous participation in the same study
- •SARS-CoV 2 positive
- •Study specific
- •Hyperphosphataemia (>4.5 mg/dL)
- •Hypersensitivity to heparin or known history of heparin induced thrombocytopenia (HIT Type II)
- •Uncontrolled bleeding and coagulation disorders
- •Decision to limit therapeutic interventions
- •Advanced malignancy (not including myeloma)
- •Dementia (if definitely not an acute confusional state from uraemia or other acute illness)
- •Advanced cirrhosis with encephalopathy in the absence of possible liver transplantation
研究组 & 干预措施
multiPlus dialysate
Experimental
Treatment of acute kidney injury patients either with continuous veno-venous haemodialysis (CVVHD) or continuous veno-venous haemodiafiltration (CVVHDF) using the multiPlus dialysate.
干预措施: multiPlus dialysate (Device)
结局指标
主要结局
Serum creatinine removal
时间窗: 360 min after start
The primary variable of this clinical investigation is serum creatinine removal (arterial pre-filter sample taking) assessed 6 hours (360 min) after start of CVVHD(F).
次要结局
未报告次要终点
研究者
研究点 (1)
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