Intraabdominal Hypertension and Occurrence of Microaspiration in Cirrhotics Under Mechanical Ventilation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorUniversity Hospital, Lille
About this trial
The study aims to demonstrate the relationship between intra-abdominal hypertension (IAH) and abundant microaspirations in mechanically ventilated cirrhotic.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adult patients
Cirrhosis
intubation and mechanical ventilation
Disqualifiers
pregnancy
oliguric patients
impossibility to measure intravesical pressure
Trial population
cirrhotic patients receiving invasive mechanical ventilation
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
226 Participants
are grouped into 2 trial groupsGroup A: intraabdominal hypertension group
Group B: control group
Trial outcomes
Primary outcomes
1
abundant microaspiration
presence of pepsin or alpha amylase at significant level in at least 30% of tracheal aspirates
Time frame
48 hours after inclusionSecondary outcomes
1
Mortality
number of death
Time frame
from ICU admission until day 282
Incidence of ventilator associated pneumonia (VAP)
percentage of patients with VAP
Time frame
from intubation until day 28 or extubation3
duration of mechanical ventilation
number of days with mechanical ventilation
Time frame
from intubation until day 28 or extubation4
incidence of patients requiring renal replacement therapy
percentage of patients with renal replacement treatment
Time frame
from ICU admission until Day 28 or ICu discharge, whichever came firstSponsors and contacts
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Source ClinicalTrials.gov