Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04530760

Intraabdominal Hypertension and Occurrence of Microaspiration in Cirrhotics Under Mechanical Ventilation

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Critical Illness Cirrhosis, Liver Digestive System Diseases Disease Attributes Fibrosis Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hop Claude Huriez Chu Lille, Lille, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients
  • Cirrhosis
  • intubation and mechanical ventilation

Exclusion criteria

  • pregnancy
  • oliguric patients
  • impossibility to measure intravesical pressure

Treatment and study plan

Primary outcomes

  1. abundant microaspiration

    Time frame: 48 hours after inclusion

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

Secondary outcomes

  1. Mortality

    Time frame: from ICU admission until day 28

    number of death

  2. Incidence of ventilator associated pneumonia (VAP)

    Time frame: from intubation until day 28 or extubation

    percentage of patients with VAP

  3. duration of mechanical ventilation

    Time frame: from intubation until day 28 or extubation

    number of days with mechanical ventilation

  4. incidence of patients requiring renal replacement therapy

    Time frame: from ICU admission until Day 28 or ICu discharge, whichever came first

    percentage of patients with renal replacement treatment

  5. incidence of cirrhosis related complications

    Time frame: from ICU admission until Day 28 or ICU discharge, whichever came first

    percentage of patients with cirrhosis related complications

Study contacts

Contact information is provided by the study sponsor or research team.

Saad Nseir, MD,PhD

CONTACT

[email protected]

0320444495 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Impact of Intraabdominal Hypertension on Microaspiration Incidence in Cirrhotic Patients

Acronym: ATOMIC

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 28, 2020
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.