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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04530760
Other study ID # 2018_75
Secondary ID 2019-A02622-55
Status Recruiting
Phase
First received
Last updated
Start date October 8, 2021
Est. completion date October 2023

Study information

Verified date March 2022
Source University Hospital, Lille
Contact Saad Nseir, MD,PhD
Phone 0320444495
Email saadalla.nseir@chru-lille.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 226
Est. completion date October 2023
Est. primary completion date October 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - adult patients - Cirrhosis - intubation and mechanical ventilation Exclusion Criteria: - pregnancy - oliguric patients - impossibility to measure intravesical pressure

Study Design


Locations

Country Name City State
France Hop Claude Huriez Chu Lille Lille
France Hop Salengro - Hopital B Lille

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary abundant microaspiration presence of pepsin or alpha amylase at significant level in at least 30% of tracheal aspirates 48 hours after inclusion
Secondary Mortality number of death from ICU admission until day 28
Secondary Incidence of ventilator associated pneumonia (VAP) percentage of patients with VAP from intubation until day 28 or extubation
Secondary duration of mechanical ventilation number of days with mechanical ventilation from intubation until day 28 or extubation
Secondary incidence of patients requiring renal replacement therapy percentage of patients with renal replacement treatment from ICU admission until Day 28 or ICu discharge, whichever came first
Secondary incidence of cirrhosis related complications percentage of patients with cirrhosis related complications from ICU admission until Day 28 or ICU discharge, whichever came first
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