NCT03562754已完成不适用
Randomized Controlled Trial of Intermittent Hemodialysis With Regional Citrate Anticoagulation Versus Systemic Low Dose Heparin Anticoagulation in Patients at Risk of Bleeding in Nephrology Intensive Care Unit
Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年3月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Duration of intermittent hemodialysis between groups
研究概览
简要总结
The study investigators hypothesize that intermittent hemodialysis with regional citrate anticoagulation (Prometheus system/Frésénius) is more efficient than reduced systemic heparin anticoagulation in patients at bleeding risk hospitalized in nephrology intensive care unit
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •The patient has been correctly informed.
- •The patient must have given his/her informed and signed consent.
- •The legal guardian or trusted-person of an adult under guardianship must have given their informed and signed consent.
- •The patient has health insurance coverage via the French social security system.
- •The patient is at least 18 years old.
- •The patient is at bleeding risk; the bleeding risk is defined by the clinical situation and according to predefined clinical situations (before or after surgery or biopsy, hemorrhage).
- •The patient requires an intermittent hemodialysis in a nephrology ICU setting.
排除标准
- •The patient is participating in, or has participated in over the past three months, another interventional trial.
- •The patient is in an exclusion period determined by a previous study.
- •The patient is under judicial protection.
- •The parents (or legal guardian) of the patient refuse to sign the consent.
- •It is impossible to correctly inform the patient/parents (or legal guardian) of the patient (language barrier).
- •Contraindication to heparin treatment.
- •Indication of continuous dialysis in ICU.
- •Pregnancy.
结局指标
主要结局
Duration of intermittent hemodialysis between groups
时间窗: End of intermittent hemodialysis session (average 4 hours)
Minutes
次要结局
- Occurrence of hemorrhage(Hour 12)
- Transmembrane pressure between groups(End of intermittent hemodialysis session (average 4 hours))
- Hemodialysis treatment adequacy(End of intermittent hemodialysis session (average 4 hours))
- Blood aspect in the extracorporeal treatment circuit(End of intermittent hemodialysis session (average 4 hours))
- Occurrence of metabolic disorders (hypocalcemia, metabolic alkalose)(Hour 12)
- Occurance of unexpected complications (almost none recorded in the literature)(End of intermittent hemodialysis session (average 4 hours))
研究者
研究点 (2)
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