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Intraabdominal Hypertension and Occurrence of Microaspiration in Cirrhotics Under Mechanical Ventilation

NCT ID: NCT04530760

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

226 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-08

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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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

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Critical Illness Cirrhosis, Liver

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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intraabdominal hypertension group

patients with intraabdominal hypertension defined as intravesical pressure more than 12 mmHg

No interventions assigned to this group

control group

patients with no intraabdominal hypertension

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* adult patients
* Cirrhosis
* intubation and mechanical ventilation

Exclusion Criteria

* pregnancy
* oliguric patients
* impossibility to measure intravesical pressure
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Saad Nseir, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hop Claude Huriez Chu Lille

Lille, , France

Site Status RECRUITING

Hop Salengro - Hopital B

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Saad Nseir, MD,PhD

Role: CONTACT

Phone: 0320444495

Email: [email protected]

Facility Contacts

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Role: primary

Role: primary

Other Identifiers

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2019-A02622-55

Identifier Type: OTHER

Identifier Source: secondary_id

2018_75

Identifier Type: -

Identifier Source: org_study_id