Intraabdominal Hypertension and Occurrence of Microaspiration in Cirrhotics Under Mechanical Ventilation (ATOMIC)

Impact of Intraabdominal Hypertension on Microaspiration Incidence in Cirrhotic Patients

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

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Cirrhosis, Liver

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 Type: Observational
• Enrollment (Estimated): 226

Contacts and Locations

• Study Contact: Name: Saad Nseir, MD,PhD; Phone Number: +33 0320444495; Email: saadalla.nseir@chru-lille.fr

Study Locations

• France
  • Lille, France, 59037
    • Recruiting
    • Hop Claude Huriez Chu Lille
    • Contact: Phone Number: 0320445962
  • Lille, France, 59037
    • Recruiting
    • Hop Salengro - Hopital B
    • Contact: Phone Number: 0320445962

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

cirrhotic patients receiving invasive mechanical ventilation

Description

Inclusion Criteria:

• adult patients
• Cirrhosis
• intubation and mechanical ventilation

Exclusion Criteria:

• pregnancy
• oliguric patients
• impossibility to measure intravesical pressure

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
intraabdominal hypertension group; patients with intraabdominal hypertension defined as intravesical pressure more than 12 mmHg
control group; patients with no intraabdominal hypertension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
abundant microaspiration	presence of pepsin or alpha amylase at significant level in at least 30% of tracheal aspirates	48 hours after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	number of death	from ICU admission until day 28
Incidence of ventilator associated pneumonia (VAP)	percentage of patients with VAP	from intubation until day 28 or extubation
duration of mechanical ventilation	number of days with mechanical ventilation	from intubation until day 28 or extubation
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
incidence of cirrhosis related complications	percentage of patients with cirrhosis related complications	from ICU admission until Day 28 or ICU discharge, whichever came first

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Saad NSEIR, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: August 27, 2020
• First Posted (Actual): August 28, 2020

Study Record Updates

• Last Update Posted (Estimated): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Digestive System Diseases; Liver Diseases; Fibrosis; Pathological Conditions, Signs and Symptoms; Critical Illness; Liver Cirrhosis
• Other Study ID Numbers: 2018_75; 2019-A02622-55 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No