跳至主要内容
临床试验/NCT05781971
NCT05781971尚未招募不适用

Department of Intensive Care Medicine, The First Affiliated Hospital of Soochow University

Jinling Hospital, China0 个研究点目标入组 1,600 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,600
主要终点
Hospital Mortality

研究概览

简要总结

Sepsis is a syndrome of life-threatening organ dysfunction caused by a dysregulated host response to infection.Acute catabolic response in critically ill patients struck by sepsis, manifested by massive protein breakdown in a short time.This pathology frequently leads to prolonged hospitalization and mechanical ventilation, increased mortality, and reduced quality of survival.It is uncertainty whether sepsis patients in ICU can benefit from high protein intake combined with early exercise. Even though the combination has been shown to be beneficial in other populations.In the present study, the investigator will evaluate the effects of a combination of high protein targets combined with early rehabilitation in sepsis patients in ICU.

详细描述

Existing research results confirm that high target protein support can reduce the mortality of sepsis patients. Early bedside rehabilitation has a good effect on cognitive function after ICU. This study combined high-protein nutritional support with bedside rehabilitation to improve the quality of life in patients with sepsis after ICU.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion Standard
  • Patients with sepsis
  • Patients aged 18-70 years
  • Time of admission ≤48 h
  • Non-terminal condition
  • Exclusion Standard
  • Severe acute kidney injury
  • Severe chronic liver disease (MELD score ≥20) or acute hepatic failure
  • Protein allergy
  • Pregnancy and lactation
  • BMI≥30 kg/m²

排除标准

  • 未提供

结局指标

主要结局

Hospital Mortality

时间窗: Day 90

Chart review

次要结局

  • Prognostic factor(Hospital discharge)
  • Physical functioning(Hospital discharge)
  • Health-related quality of life(Day 90)
  • Nutrition related indicators(Hospital discharge)

研究者

发起方
Jinling Hospital, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yao Wei,MD

associate chief physician

The First Affiliated Hospital of Soochow University

相似试验