Intraabdominal Hypertension and Occurrence of Microaspiration in Cirrhotics Under Mechanical Ventilation

Critical Illness Clinical Trial

— ATOMIC  

Official title:

Impact of Intraabdominal Hypertension on Microaspiration Incidence in Cirrhotic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04530760
• Other study ID #: 2018_75
• Secondary ID: 2019-A02622-55
• Status: Recruiting
• Start date: October 8, 2021
• Est. completion date: October 2023

Study information

• Verified date: March 2022
• Source: University Hospital, Lille
• Contact: Saad Nseir, MD,PhD
• Phone: 0320444495
• Email: saadalla.nseir[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 226
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• adult patients
• Cirrhosis
• intubation and mechanical ventilation

Exclusion Criteria:

• pregnancy
• oliguric patients
• impossibility to measure intravesical pressure

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Critical Illness
• Hypertension
• Intra-Abdominal Hypertension
• Liver Cirrhosis

Locations

Country	Name	City	State
France	Hop Claude Huriez Chu Lille	Lille
France	Hop Salengro - Hopital B	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	abundant microaspiration	presence of pepsin or alpha amylase at significant level in at least 30% of tracheal aspirates	48 hours after inclusion
Secondary	Mortality	number of death	from ICU admission until day 28
Secondary	Incidence of ventilator associated pneumonia (VAP)	percentage of patients with VAP	from intubation until day 28 or extubation
Secondary	duration of mechanical ventilation	number of days with mechanical ventilation	from intubation until day 28 or extubation
Secondary	incidence of patients requiring renal replacement therapy	percentage of patients with renal replacement treatment	from ICU admission until Day 28 or ICu discharge, whichever came first
Secondary	incidence of cirrhosis related complications	percentage of patients with cirrhosis related complications	from ICU admission until Day 28 or ICU discharge, whichever came first