Critical IllnessATOMICNCT04530760
Intraabdominal Hypertension and Occurrence of Microaspiration in Cirrhotics Under Mechanical Ventilation
An observational study of Critical Illness and Cirrhosis, Liver, run by University Hospital, Lille at 2 sites in France.
Trial summary
The study aims to demonstrate the relationship between intra-abdominal hypertension (IAH) and abundant microaspirations in mechanically ventilated cirrhotic. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Critical Illness, Cirrhosis, Liver
- How many people
- 226 participants
- Where
- 2 sitesFrance
- Study dates
- 8 Oct 2021to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: cirrhotic patients receiving invasive mechanical ventilation
Who may be able to join
- adult patients
- Cirrhosis
- intubation and mechanical ventilation
Who cannot join
- pregnancy
- oliguric patients
- impossibility to measure intravesical pressure
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Hop Claude Huriez Chu Lille
Lille, 59037
0320445962
- Recruiting
Hop Salengro - Hopital B
Lille, 59037
0320445962
About this study
Official title: 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.
Read the 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.
- Conditions
- Critical Illness, Cirrhosis, Liver
- Medical subject headings
- Critical Illness, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| intraabdominal hypertension group | patients with intraabdominal hypertension defined as intravesical pressure more than 12 mmHg | |
| control group | patients with no intraabdominal hypertension |
What is being measured
The primary outcome is the main question the study is designed to answer.
abundant microaspiration
presence of pepsin or alpha amylase at significant level in at least 30% of tracheal aspirates
Measured: 48 hours after inclusion
Secondary outcomes (5)
Mortality
number of death
Measured: from ICU admission until day 28
Incidence of ventilator associated pneumonia (VAP)
percentage of patients with VAP
Measured: from intubation until day 28 or extubation
duration of mechanical ventilation
number of days with mechanical ventilation
Measured: from intubation until day 28 or extubation
incidence of patients requiring renal replacement therapy
percentage of patients with renal replacement treatment
Measured: from ICU admission until Day 28 or ICu discharge, whichever came first
incidence of cirrhosis related complications
percentage of patients with cirrhosis related complications
Measured: from ICU admission until Day 28 or ICU discharge, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start8 Oct 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saad Nseir, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530760
- Sponsor's protocol ID
- 2018_75
- Other IDs
- 2019-A02622-55
- Acronym
- ATOMIC
- Status last verified
- Dec 2025
- First submitted
- 27 Apr 2020
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intraabdominal Hypertension on Microaspiration Incidence in Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT04530760
- Acronym / sponsor ID
- ATOMIC / 2018_75
- Conditions
- Critical Illness, Cirrhosis, Liver
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intraabdominal hypertension group | – | –patients with intraabdominal hypertension defined as intravesical pressure more than 12 mmHg |
| control group | – | –patients with no intraabdominal hypertension |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cirrhotic patients receiving invasive mechanical ventilation
Key inclusion criteria (3 listed)
- adult patients
- Cirrhosis
- intubation and mechanical ventilation
Key exclusion criteria (3 listed)
- pregnancy
- oliguric patients
- impossibility to measure intravesical pressure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
abundant microaspiration
Time frame: 48 hours after inclusion
presence of pepsin or alpha amylase at significant level in at least 30% of tracheal aspirates
5 secondary outcomes
Mortality
Time frame: from ICU admission until day 28
Incidence of ventilator associated pneumonia (VAP)
Time frame: from intubation until day 28 or extubation
duration of mechanical ventilation
Time frame: 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
incidence of cirrhosis related complications
Time frame: from ICU admission until Day 28 or ICU discharge, whichever came first
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Saad Nseir, MD,PhD principal investigator
University Hospital, Lille
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Cirrhosis, Liver, run by University Hospital, Lille at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saad Nseir, MD,PhD (0320444495 ext. +33, saadalla.nseir@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
abundant microaspiration (time frame: 48 hours after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.