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CirrhosisFREELIVERNCT05244005

Extubation Failure in Critically Ill Cirrhotic Patients.

An observational study of Cirrhosis and Mechanical Ventilation Complication, run by University Hospital, Montpellier at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Although a life-saving intervention, invasive mechanical ventilation (MV) prone to complications and side effects. Cirrhotic patients with a need of prolonged MV have a poor prognosis in ICU compared to general population of critically ill patients. Read more about this study

Who is it for?
Ages 18 years and older
How many people
100 participants
Where
1 siteFrance
Study dates
1 Feb 2022to 31 Jan 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Consecutive critically ill patients admitted to the intensive care unit of Saint Eloi University teaching hospital with a history or diagnosis of cirrhosis and requiring invasive mechanical ventilation for more than 6 hours.

Who may be able to join

  • Adult patients
  • Known history of cirrhosis or diagnosis of cirrhosis during the ICU stay
  • Invasive mechanical ventilation for more than 6 hours
  • Eligible for extubation according to the physician in charge

Who cannot join

  • Pregnancy,
  • Age below 18
  • Terminal extubation
  • Absence of consent

Trial locations and contacts

1 site in 1 country.

France1 site, 1 recruiting
  • Uhmontpellier

    Montpellier, 34295

    Yassir AARAB, MD, 467337271 ext. 33, y-aarab@chu-montpellier.fr

    Recruiting

Other trials in France

About this study

Official title: Incidence, Risk Factors and Outcomes for Early and Delayed Extubatiion Failure in Critically Ill Cirrhotic Patients

Although a life-saving intervention, invasive mechanical ventilation (MV) prone to complications and side effects.

Cirrhotic patients with a need of prolonged MV have a poor prognosis in ICU compared to general population of critically ill patients. The optimal time for weaning from MV and extubation is therefore a crucial objective. Extubation failure is defined as the need for reintubation within 48-72 hours (early). This time frame is sometimes extended to 7 days (delayed), especially when noninvasive ventilation is used during extubation (SFAR-SRLF 2018 recommendations). Some studies have investigated the risk factors for extubation failure in general population of critically ill patients, and in some specific subpopulations (COPD, brain injury, elderly). But little is known about extubation failure in cirrhotic patients admitted in ICU.

The aim of the present study is to describe the incidence and identify specific risk factors for extubation failure in cirrhotic critically ill patients. Ultrasound and clinical data will be collected and analysed during the ICU stay.

Read the detailed description

Mechanical ventilation (MV) is a life saving therapy for many critically ill patients. However, it is associated with major complications (ventilator-associated pneumonia, resuscitation neuromyopathy, etc.) that affect the prognosis. The optimal time for weaning from MV and extubation is therefore a major question. The decision to extubate is usually made as soon as the patient meets predefined weaning criteria and succed a spontaneous breathing test (SBT). However, extubation failure occurs in 10 to 20% of patients who suceeded an SBT in general critically ill patients. Extubation failure is defined as the need for reintubation within 48-72 hours. This time frame is sometimes extended to 7 days, especially when noninvasive ventilation is used during extubation (SFAR-SRLF 2018 recommendations). Early and delayed extubation Failure are then defines as failure within 48 hours and between day 2 and day 7 respectively. The decision to extubate in even more challenging because failure is associated with an overall increase in the duration of MV, an increased need for tracheostomy, higher medical costs but also particularly higher mortality. There is also evidence that extubation failure is not only a marker of more severe disease, but independently affects patient survival, regardless of the severity of the underlying disease.

Cirrhotic patients represent 5 to 8% of all ICU admissions. Their mortality is significantly higher than the general population (34 to 69% depending on the reason for admission). The need for MV is one of the main causes of admission of cirrhotic patients to the ICU, but it is also one of their main risk factors for mortality (60 to 91% for MV cirhhotic patients in ICU). The proportion of cirrhotic patients admitted to the ICU is constantly increasing due to the improvement of the global prognosis linked to novel therapies (transjugular intrahepatic porto-systemic shunt, liver dialysis, liver transplantation). Numerous studies have investigated the risk factors for extubation failure in critically ill patients. The largest multicenter cohort (FREE-REA study, sponsor CHU of Montpellier, first author Pr Samir Jaber, PMCID: PMC6151191), included 11% of cirrhotic patients out of 1453 patients in total. A post-hoc analysis of these data showed similar incidences of extubation failure at H48 between cirrhotic and non-cirrhotic patients (10.5% Vs 9.1%; p=0.57) but a higher incidence of delayed extubation failure (at D7) in cirrhotic patients (18.9% Vs 11.5%; p<0.01). However, the specific causes and risk factors were not clearly identified, and no study to date has specifically looked at this population and its risk factors for extubation failure.

The aim of the present study is to describe the incidence and identify specific risk factors for extubation failure in cirrhotic critically ill patients. Ultrasound and clinical data will be collected and analysed during the ICU stay

Keywords
Extubation failure, Mechanical ventilation, Risk factors
Medical subject headings
Fibrosis, Critical Illness

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of extubation failure

    Incidence of extubation failure in cirrhotic patients ventilated for more than 6 hours in the ICU

    Measured: From extubation (day 0) to day 7 after extubation

Secondary outcomes (1)
  1. Risk factors for extubation failure

    Risk factors for extubation failure

    Measured: From extubation (day 0) to day 7 after extubation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2022
  2. Study start1 Feb 2022
  3. Primary completion1 Jan 2023 (estimated)
  4. Study completion31 Jan 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05244005
Sponsor's protocol ID
RECHMPL21_0731
Acronym
FREELIVER
Status last verified
Feb 2022
First submitted
10 Jan 2022
Last updated
17 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: NC

Questions about this trial

What is this clinical trial studying?

An observational study of Cirrhosis and Mechanical Ventilation Complication, run by University Hospital, Montpellier at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yassir AARAB, MD (467337271 ext. 33, y-aarab@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of extubation failure (time frame: From extubation (day 0) to day 7 after extubation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.

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