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临床试验/NCT05379582
NCT05379582已完成不适用

The Effect of Early Enteral Nutrition Feeding Process Assisted by Gastrointestinal Ultrasonography in Critically Ill Patients

Chinese Medical Association1 个研究点 分布在 1 个国家目标入组 294 人开始时间: 2022年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
294
试验地点
1
主要终点
Target-reaching rate through enteral route

研究概览

简要总结

In critical ill patients, feeding protocol is one of the important factor which determines the successful implementation of enteral nutrition(EN). Acute gastrointestinal injury(AGI) affects feeding tolerance, which greatly determines the successful implementation of feeding protocol. In our previously study, we found that transabdominal intestinal sonography is helpful to diagnosis AGI. Thus in this study ,we apply transabdominal gastrointestinal sonography to feeding protocol, to assess the feasibility of gastrointestinal sonography assisted enteral nutrition and its impact on critical ill patients.

详细描述

Patients meeting inclusion and exclusion criteria were randomly assigned to the intervention group and control group. During the first week of initiation of nutrition, enteral nutrition was conducted according to different procedures to observe the impact of different feeding procedures on clinical indicators

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
Quadruple (Participant, Care Provider, Investigator, 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

入选标准

  • The age is not less than 18 years
  • within 24 hours after entering ICU
  • Acute Physiology and Chronic Health Evaluation II (APACHE II) score > 8
  • the estimated length of stay in ICU is more than 3 days
  • informed consent

排除标准

  • The normal anatomy of stomach, small intestine or the right colon was significantly changed (Gastrectomy, esophagectomy, pancreaticoduodenectomy, gastrointestinal bypass surgery, the presence of short bowel syndrome,etc.)
  • Uncontrolled gastrointestinal bleeding
  • Uncontrolled intestinal obstruction
  • Uncontrolled mesenteric vascular disease
  • Pregnancy
  • breastfeeding
  • Received enteral nutrition or parenteral nutrition within 24 hours prior to ICU admission
  • Predict death within 48 hours after ICU admission
  • Enrolled in this study before.

研究组 & 干预措施

control group

No Intervention

Implement nutrition therapy according to existing feeding procedures

intervention group

Experimental

Implement nutrition therapy according a procedure assisted by gastrointestinal ultrasound

干预措施: Implement nutrition therapy according a procedure assisted by gastrointestinal ultrasound (Other)

结局指标

主要结局

Target-reaching rate through enteral route

时间窗: Within first week

percentage of participants who reach target calorie through enteral route

次要结局

  • Total bilirubin(Day0,1,3,5,7)
  • Serum creatinine(Day0,1,3,5,7)
  • The incidence of feeding intolerance(Within first week)
  • The application of parenteral nutrition(Within first week)
  • The application of prokinetic drugs(Within first week)
  • The ues of vasoactive drugs(Within first week)
  • Mechanical ventilation(Within first week)
  • Continuous renal replacement(Within first week)
  • The CRP level(Day0/1/3/5/7)
  • Mortality(Day28、Day60、during hospitalization)
  • ICU length of stay(During ICU stay)
  • Length of hospital stay(During hospital stay)
  • Platelet count(Day0,1,3,5,7)

研究者

申办方类型
Network
责任方
Sponsor

研究点 (1)

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