Intraabdominal Hypertension and Occurrence of Microaspiration in Cirrhotics Under Mechanical Ventilation

• Conditions: Critical Illness; Cirrhosis, Liver

• Registration Number: NCT04530760
• Lead Sponsor: University Hospital, Lille

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-08-27
• Study First Posted: 2020-08-28
• Study Start: 2021-10-08
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-17
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 226

Inclusion Criteria

• adult patients
• Cirrhosis
• intubation and mechanical ventilation

Exclusion Criteria

• pregnancy
• oliguric patients
• impossibility to measure intravesical pressure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
abundant microaspiration	48 hours after inclusion	presence of pepsin or alpha amylase at significant level in at least 30% of tracheal aspirates

Secondary Outcome Measures

Name	Time	Method
duration of mechanical ventilation	from intubation until day 28 or extubation	number of days with mechanical ventilation
Incidence of ventilator associated pneumonia (VAP)	from intubation until day 28 or extubation	percentage of patients with VAP
incidence of patients requiring renal replacement therapy	from ICU admission until Day 28 or ICu discharge, whichever came first	percentage of patients with renal replacement treatment
incidence of cirrhosis related complications	from ICU admission until Day 28 or ICU discharge, whichever came first	percentage of patients with cirrhosis related complications
Mortality	from ICU admission until day 28	number of death

Trial Locations

Locations (2)

Hop Claude Huriez Chu Lille; 🇫🇷 Lille, France

Hop Salengro - Hopital B; 🇫🇷 Lille, France