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.
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
- Conditions the study is for
- Cirrhosis, Mechanical Ventilation Complication, Critical Illness
- 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.
Albert PRADES contact
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
Yassir AARAB, MD, 467337271 ext. 33, y-aarab@chu-montpellier.fr
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.
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)
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.
- First posted17 Feb 2022
- Study start1 Feb 2022
- Primary completion1 Jan 2023 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yassir AARAB, Principal investigator, University Hospital, Montpellier
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Risk Factors and Outcomes for Early and Delayed Extubatiion Failure in Critically Ill Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT05244005
- Acronym / sponsor ID
- FREELIVER / RECHMPL21_0731
- Keywords
- Extubation failure, Mechanical ventilation, Risk factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnancy,
- Age below 18
- Terminal extubation
- Absence of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of extubation failure
Time frame: From extubation (day 0) to day 7 after extubation
Incidence of extubation failure in cirrhotic patients ventilated for more than 6 hours in the ICU
1 secondary outcome
Risk factors for extubation failure
Time frame: From extubation (day 0) to day 7 after extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert PRADES contact
Yassir AARAB principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
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.