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临床试验/NCT02384525
NCT02384525Unknown不适用

The Assessment of Volume Status by BIA and Lung Ultrasound in Septic AKI Patients Undergoing CRRT

Yonsei University2 个研究点 分布在 1 个国家目标入组 218 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
218
试验地点
2
主要终点
28-day all cause mortality

研究概览

简要总结

Acute kidney injury(AKI) is one of the most common complications that occur up to 35% of critically ill patients. Septic AKI accounts for one third of them. Patients with septic AKI are widely treated with Continuous renal replacement therapy (CRRT). However, previous studies have hardly documented improvement of mortality in septic AKI patients. Otherwise, Fluid overload in septic shock patients who are undergoing CRRT is proven to be a significant predictor for mortality. Recent studies showed efficacy of bioelectrical impedance analysis and lung ultrasound in assessing fluid status of the patients. Thus, hypothesis of the study is that fluid assessment and control of fluid status using BIA and Lung Ultrasound could be related to the outcome of septic AKI patients who undergo CRRT. In this study, the investigators measure the fluid status of the patients by bioelectrical impedance analysis and lung ultrasound for experimental group, while for control group, fluid status would be determined clinically by the physician. Ultrafiltration rate of experimental group is adjusted to be equal to the value of overhydration measured by BIA.

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
19 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • body temperature < 36 °C or > 38 °C
  • heart rate > 90 BPM
  • respiratory rate > 20 or aPaCO2 < 32 mmHg on ABG
  • White blood cell count < 4,000 cells/mm3 or > 12,000 cells/mm3 or band forms (immature white blood cells) ≥10%
  • Evidence of infection
  • WBCs in normally sterile fluid
  • Perforated viscus
  • radiologically proven infection
  • more than Injury stage in AKI according to RIFLE criteria
  • septic AKI which is not explained by other cause
  • patients signed a written informed consent.

排除标准

  • Younger than 19 years old, older than 80 years old
  • Previously undergoing dialysis treatment due to ESRD
  • Underlying malignancy, Life expectancy shorter than 3 month
  • AKI due to other than sepsis
  • patients with intracardiac device such as Pacemaker, CRT, ICD

研究组 & 干预措施

clinical-based ultrafiltration

Experimental

干预措施: Fluid management by the value of over hydration in Bioelectrical impedance (Procedure)

BIA-based ultrafiltration

Active Comparator

干预措施: Fluid management by clinical-based ultrafiltration (Procedure)

结局指标

主要结局

28-day all cause mortality

时间窗: 28th day from CRRT

次要结局

  • Dialysis free rate(9 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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