NCT04530760

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Oct 2021

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Oct 2021Dec 2026

First Submitted

Initial submission to the registry

April 27, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 28, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 8, 2021

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

5.2 years

First QC Date

April 27, 2020

Last Update Submit

December 16, 2025

Conditions

Cirrhosis, LiverCritical Illness

Outcome Measures

Primary Outcomes (1)

  • abundant microaspiration

    presence of pepsin or alpha amylase at significant level in at least 30% of tracheal aspirates

    48 hours after inclusion

Secondary Outcomes (5)

  • Mortality

    from ICU admission until day 28

  • Incidence of ventilator associated pneumonia (VAP)

    from intubation until day 28 or extubation

  • duration of mechanical ventilation

    from intubation until day 28 or extubation

  • incidence of patients requiring renal replacement therapy

    from ICU admission until Day 28 or ICu discharge, whichever came first

  • incidence of cirrhosis related complications

    from ICU admission until Day 28 or ICU discharge, whichever came first

Study Arms (2)

intraabdominal hypertension group

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

control group

patients with no intraabdominal hypertension

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

cirrhotic patients receiving invasive mechanical ventilation

You may qualify if:

  • adult patients
  • Cirrhosis
  • intubation and mechanical ventilation

You may not qualify if:

  • pregnancy
  • oliguric patients
  • impossibility to measure intravesical pressure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hop Claude Huriez Chu Lille

Lille, 59037, France

RECRUITING

Hop Salengro - Hopital B

Lille, 59037, France

RECRUITING

MeSH Terms

Conditions

Critical IllnessLiver Cirrhosis

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLiver DiseasesDigestive System DiseasesFibrosis

Study Officials

  • Saad Nseir, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Saad Nseir, MD,PhD

CONTACT

0320444495saadalla.nseir@chru-lille.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2020

First Posted

August 28, 2020

Study Start

October 8, 2021

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

December 23, 2025

Record last verified: 2025-12

Locations

FR(2)