Intraabdominal Hypertension and Occurrence of Microaspiration in Cirrhotics Under Mechanical Ventilation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Critical Illness, Cirrhosis, Liver. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Intraabdominal Hypertension on Microaspiration Incidence in Cirrhotic Patients
Overview
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.
Primary outcome measures
- abundant microaspiration [Time frame: 48 hours after inclusion]
Secondary outcome measures (5)
- 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]
Eligibility criteria
Inclusion criteria
- adult patients
- Cirrhosis
- intubation and mechanical ventilation
Exclusion criteria
- pregnancy
- oliguric patients
- impossibility to measure intravesical pressure
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 2 centers
- Hop Claude Huriez Chu Lille — Lille
- Hop Salengro - Hopital B — Lille
Identifiers
NCT: NCT04530760 · 2018_75 · 2019-A02622-55