VolumE maNagement Under Body Composition Monitoring in Critically Ill patientS on CRRT; Randomized-controlled Trial (VENUS Trial)
试验速览
- 阶段
- 不适用
- 入组人数
- 244
- 试验地点
- 2
- 主要终点
- The rate reaching euvolemia
研究概览
简要总结
Although monitoring fluid balance for continuous renal replacement therapy-treated patients is an important issue, most physicians usually use conventional methods such as the difference between the amount of intake and output (I & O), which is not objective way. Meanwhile, bioimpedance electrical vector analysis presents the patients' fluid status with more objective data. Thus, the investigators will investigate the clinical benefit for monitoring fluid balance when the investigators use InBody S10, one of representative bioimpedance electrical vector analysis, compared with conventional methods among the patients who need continuous renal replacement therapy.
详细描述
Although monitoring fluid balance for continuous renal replacement therapy-treated patients is an important issue, most physicians usually use conventional methods such as the difference between the amount of intake and output (I & O), which is not objective way.
Meanwhile, bioimpedance electrical vector analysis presents the patients' fluid status with more objective data.
Thus, the investigators will investigate the clinical benefit for monitoring fluid balance by using InBody S10 (0, 1, 2-day, and 7-day from CRRT initiation), one of representative bioimpedance electrical vector analysis, compared with conventional methods among the patients who need continuous renal replacement therapy.
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
- 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
- •Patients will be eligible for INCLUSION in the study if ALL the following criteria are met;
- •The treating clinician believes that the patient requires continuous renal replacement therapy for acute renal failure.
- •The treating clinicians anticipate treating the patient with continuous renal replacement therapy for at least 72 hours.
- •Informed consent has been obtained.
- •The patient fulfills ONE of the following clinical criteria for initiating continuous renal replacement therapy:
- •urine output < 100 ml/6 hr that has been unresponsive to fluid resuscitation measures
- •K+> 6.5 mmol/L
- •pH < 7.2
- •Urea > 25 mmol/L
- •Clinically significant organ edema in the setting of acute kidney injury
- •Patients who are over 5% of fluid overload or their total body water/height^2 ≥13 L/m^2
排除标准
- •Patients will be EXCLUDED from the study if, in the opinion or knowledge of the responsible clinician ANY of the following criteria are present:
- •Patient age is < 18 years
- •Death is imminent (<24 hours)
- •There is a strong likelihood that the study treatment will not be continued in accordance with the study protocol.
- •The patient has been treated with continuous renal replacement therapy or other dialysis previously during the same hospital admission.
- •The patient has been on maintenance dialysis prior to the current hospitalization.
- •Any other major illness that, in the investigator's judgement, will substantially increase the risk associated with the subject's participation in this study.
结局指标
主要结局
The rate reaching euvolemia
时间窗: 7 days from CRRT initiation
To compare how many rates the two groups reach the euvolemia at 7 days from CRRT initiation
次要结局
- Clinical outcomes (28-, 60-, 90-day mortality)(28-, 60-, or 90-days)
研究者
Sejoong Kim
Associate Professor
Seoul National University Hospital