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

March 14, 2022 updated by: University Hospital, Lille

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

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 (Anticipated)

226

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lille, France, 59037
        • Recruiting
        • Hop Claude Huriez Chu Lille
      • Lille, France, 59037
        • Recruiting
        • Hop Salengro - Hopital B

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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
Time Frame: 48 hours after inclusion
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
Time Frame: from ICU admission until day 28
number of death
from ICU admission until day 28
Incidence of ventilator associated pneumonia (VAP)
Time Frame: from intubation until day 28 or extubation
percentage of patients with VAP
from intubation until day 28 or extubation
duration of mechanical ventilation
Time Frame: from intubation until day 28 or extubation
number of days with mechanical ventilation
from intubation until day 28 or extubation
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
from ICU admission until Day 28 or ICu discharge, whichever came first
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
from ICU admission until Day 28 or ICU discharge, whichever came first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2021

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

October 1, 2023

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 (Actual)

March 17, 2022

Last Update Submitted That Met QC Criteria

March 14, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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