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临床试验/NCT04530760
NCT04530760招募中不适用

Impact of Intraabdominal Hypertension on Microaspiration Incidence in Cirrhotic Patients

University Hospital, Lille2 个研究点 分布在 1 个国家目标入组 226 人开始时间: 2021年10月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
226
试验地点
2
主要终点
abundant microaspiration

研究概览

简要总结

The study aims to demonstrate the relationship between intra-abdominal hypertension (IAH) and abundant microaspirations in mechanically ventilated cirrhotic.

详细描述

Intra-abdominal pressure monitoring will be performed using intra-vesical pressure every 8 hour in the first 2 days of mechanical ventilation.

Micro aspiration is defined by pepsin or amylase positivity in trachea suction. Two groups will be compared : one with IAH , one without IAH.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult patients
  • Cirrhosis
  • intubation and mechanical ventilation

排除标准

  • pregnancy
  • oliguric patients
  • impossibility to measure intravesical pressure

结局指标

主要结局

abundant microaspiration

时间窗: 48 hours after inclusion

presence of pepsin or alpha amylase at significant level in at least 30% of tracheal aspirates

次要结局

  • duration of mechanical ventilation(from intubation until day 28 or extubation)
  • Incidence of ventilator associated pneumonia (VAP)(from intubation until day 28 or extubation)
  • incidence of patients requiring renal replacement therapy(from ICU admission until Day 28 or ICu discharge, whichever came first)
  • incidence of cirrhosis related complications(from ICU admission until Day 28 or ICU discharge, whichever came first)
  • Mortality(from ICU admission until day 28)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (2)

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