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Intraabdominal Hypertension and Occurrence of Microaspiration in Cirrhotics Under Mechanical Ventilation

Impact of Intraabdominal Hypertension on Microaspiration Incidence in Cirrhotic Patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04530760
Acronym
ATOMIC
Enrollment
226
Registered
2020-08-28
Start date
2021-10-08
Completion date
2026-12-31
Last updated
2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Liver, Critical Illness

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.

Interventions

None listed

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* adult patients * Cirrhosis * intubation and mechanical ventilation

Exclusion criteria

* pregnancy * oliguric patients * impossibility to measure intravesical pressure

Design outcomes

Primary

MeasureTime frameDescription
abundant microaspiration48 hours after inclusionpresence of pepsin or alpha amylase at significant level in at least 30% of tracheal aspirates

Secondary

MeasureTime frameDescription
Mortalityfrom ICU admission until day 28number of death
Incidence of ventilator associated pneumonia (VAP)from intubation until day 28 or extubationpercentage of patients with VAP
duration of mechanical ventilationfrom intubation until day 28 or extubationnumber of days with mechanical ventilation
incidence of patients requiring renal replacement therapyfrom ICU admission until Day 28 or ICu discharge, whichever came firstpercentage of patients with renal replacement treatment
incidence of cirrhosis related complicationsfrom ICU admission until Day 28 or ICU discharge, whichever came firstpercentage of patients with cirrhosis related complications

Countries

France

Contacts

Primary ContactSaad Nseir, MD,PhD
saadalla.nseir@chru-lille.fr0320444495

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026