Intraabdominal Hypertension and Occurrence of Microaspira... | NCT04530760

Studies
Intraabdominal Hypertension and Occurrence of Microaspiration in Cirrhotics Under Mechanical Ventilation

NCT04530760

Sponsor

University Hospital, Lille

Status

Recruiting

Last Update Posted

Dec 23, 2025Actual

Enrollment

226Estimated

Phase

Not provided

Conditions

Critical Illness
Cirrhosis, Liver

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2019-A02622-55	Other Identifier	ID-RCB number,ANSM

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 8, 2021Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Apr 27, 2020

First Submission Date that Met QC Criteria

Aug 27, 2020

First Posted Date

Aug 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2025

Last Update Posted Date

Dec 23, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

226Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intraabdominal hypertension group		patients with intraabdominal hypertension defined as intravesical pressure more than 12 mmHg
control group		patients with no intraabdominal hypertension

Interventions

Not provided

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult patients
Cirrhosis
intubation and mechanical ventilation

Exclusion Criteria:

pregnancy
oliguric patients
impossibility to measure intravesical pressure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

cirrhotic patients receiving invasive mechanical ventilation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Saad Nseir, MD,PhD	Contact	0320444495	+33	saadalla.nseir@chru-lille.fr

Overall Officials

Name	Affiliation	Role
Saad Nseir, MD,PhD	University Hospital, Lille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hop Claude Huriez Chu Lille	Recruiting	Lille		59037	France

Condition Browse Module

MeSH Terms

ID	Term
D016638	Critical Illness
D008103	Liver Cirrhosis

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D008107	Liver Diseases

Browse Leaves

Not provided

Browse Branches

Not provided