Weaning FailureBIOMEXICNCT05637099
The Value of Repeated BIOMarker Measurements During an SBT to Predict EXtubation Failure in ICU Patients
An observational study of Weaning Failure and Mechanical Ventilation, run by Henrik Endeman at 1 site in Netherlands.
Trial summary
The Value of Repeated BIOMarker Measurements During an SBT to Predict EXtubation Failure in Mechanically Ventilated ICU Patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning Failure, Mechanical Ventilation, Spontaneous Breathing Trial
- How many people
- 181 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Aug 2022to 29 Apr 2026
- 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: Adult patients admitted to the ICUs of the Erasmus MC, the Franciscus Gasthuis \& Vlietland, Groene Hart ziekenhuis, Amphia ziekenhuis, and OLVG, who are mechanically ventilated for more than 48 hours.
Who may be able to join
- Aged ≥18 years
- Mechanically ventilated for more than 48 hours
- Fulfilling readiness-to wean criteria
- Written informed consent from the patient or his/her legal representative
Who cannot join
- Patients with risk factors for laryngeal oedema and a negative cuff leak test (indicating upper airway obstruction with need for steroid treatment)
- Planned replacement of the endotracheal tube for a tracheostomy
- Terminal illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Value of Repeated Biomarker Measurements During an SBT to Predict Extubation Failure in Mechanically Ventilated ICU Patients
The Value of Repeated BIOMarker Measurements During an SBT to Predict EXtubation Failure in Mechanically Ventilated ICU Patients
Read the detailed description
Rationale: In order to prevent extubation failure or unnecessary prolonged ventilation, accurately predicting readiness for extubation is of key importance in ICU care. Currently, clinical criteria and spontaneous breathing trials (SBTs) are used to assess readiness for extubation. Data on the prognostic value of biomarkers in this setting are limited.
Objective: To investigate the association of biomarker measurements (NT-proBNP, hsTroponin-T, CKMB, myoglobin, GDF-15, CRP, IL-6, PCT, Cystatin-C, CA-125, galectin-3, ST-2, albumin) during an SBT with extubation failure in mechanically ventilated ICU patients.
Study design: Multi-centre prospective observational cohort study.
Study population: Adult ICU patients who are mechanically ventilated for more than 48 hours and fulfil readiness-to wean criteria.
Main study parameters/endpoints: Extubation failure (the need for reintubation within 7-days).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This study will collect data that is clinically available, but also encompasses repeated biomarker measurements, cardiopulmonary echographic examination and electrocardiography. Because almost all mechanically ventilated ICU patients have an arterial line, blood can be easily sampled without venepuncture and poses negligible risks for the study patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation failure
The number of patients who were re-intubated within the next 7 days after extubation
Measured: 7 days
All-cause mortality
The number of patients who died within 7 days after extubation
Measured: 7-days
Secondary outcomes (8)
Rescue non-invasive ventilation or high-flow nasal oxygen for post-extubation respiratory insufficiency
The number of patients with rescue non-invasive ventilation or high-flow nasal oxygen for post-extubation respiratory insufficiency
Measured: 7 days
Extubation failure within 48 hours and 72 hours
The number of patients who re-intubated 48- and 72 hours after extubation
Measured: 48 hours and 72 hours
ICU length of stay post-extubation for medical reasons
The length of stay that patients were admitted in the ICU after extubation
Measured: Up to 1 year
ICU re-admission rate within current hospitalization
The number of patients who were readmitted in the ICU within the current hospitalization
Measured: Up to 1 year
All-cause mortality: ICU, hospital, 28-days, 3 and 12 months
The number of patients that died in the ICU, hospital, at 28-days, 3- and 12-months
Measured: 28-days, 3 and 12 months
Major adverse cardiac event
The number of patients that had a major adverse cardiovascular events (total death, myocardial infarction, coronary revascularization, stroke, and hospitalization because of heart failure or arrhythmia)
Measured: 3 and 12 months
Quality of life of patients after ICU and hospital admission
The quality of life will be measured using the RAND-36 (Units on a scale)
Measured: 3 and 12 months
Quality of life of patients after ICU and hospital admission
The quality of life will be measured using the EQ-5D questionnaire (Units on a scale)
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start1 Aug 2022
- Primary completion7 May 2025
- Study completion29 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning FailureStudies of the same condition, open and under way.
- 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
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henrik Endeman
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Responsible party
- Sponsor-investigator, Henrik Endeman, Erasmus Medical Center
- Investigators
- H. Endeman, Dr., Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637099
- Sponsor's protocol ID
- NL77372.078.21
- Acronym
- BIOMEXIC
- Status last verified
- Jun 2026
- First submitted
- 7 Sep 2022
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Repeated Biomarker Measurements During an SBT to Predict Extubation Failure in Mechanically Ventilated ICU Patients
- ClinicalTrials.gov ID
- NCT05637099
- Acronym / sponsor ID
- BIOMEXIC / NL77372.078.21
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Henrik EndemanUniversity, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 7 May 2025 (actual)
- Study completion
- 29 Apr 2026 (actual)
- First posted
- 5 Dec 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.
The Value of Repeated BIOMarker Measurements During an SBT to Predict EXtubation Failure in Mechanically Ventilated ICU Patients
Detailed description
Rationale: In order to prevent extubation failure or unnecessary prolonged ventilation, accurately predicting readiness for extubation is of key importance in ICU care. Currently, clinical criteria and spontaneous breathing trials (SBTs) are used to assess readiness for extubation. Data on the prognostic value of biomarkers in this setting are limited.
Objective: To investigate the association of biomarker measurements (NT-proBNP, hsTroponin-T, CKMB, myoglobin, GDF-15, CRP, IL-6, PCT, Cystatin-C, CA-125, galectin-3, ST-2, albumin) during an SBT with extubation failure in mechanically ventilated ICU patients.
Study design: Multi-centre prospective observational cohort study.
Study population: Adult ICU patients who are mechanically ventilated for more than 48 hours and fulfil readiness-to wean criteria.
Main study parameters/endpoints: Extubation failure (the need for reintubation within 7-days).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This study will collect data that is clinically available, but also encompasses repeated biomarker measurements, cardiopulmonary echographic examination and electrocardiography. Because almost all mechanically ventilated ICU patients have an arterial line, blood can be easily sampled without venepuncture and poses negligible risks for the study patients.
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
- Adult patients admitted to the ICUs of the Erasmus MC, the Franciscus Gasthuis \& Vlietland, Groene Hart ziekenhuis, Amphia ziekenhuis, and OLVG, who are mechanically ventilated for more than 48 hours.
Key inclusion criteria (4 listed)
- Aged ≥18 years
- Mechanically ventilated for more than 48 hours
- Fulfilling readiness-to wean criteria
- Written informed consent from the patient or his/her legal representative
Key exclusion criteria (3 listed)
- Patients with risk factors for laryngeal oedema and a negative cuff leak test (indicating upper airway obstruction with need for steroid treatment)
- Planned replacement of the endotracheal tube for a tracheostomy
- Terminal illness
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
Extubation failure
Time frame: 7 days
The number of patients who were re-intubated within the next 7 days after extubation
All-cause mortality
Time frame: 7-days
The number of patients who died within 7 days after extubation
8 secondary outcomes
Rescue non-invasive ventilation or high-flow nasal oxygen for post-extubation respiratory insufficiency
Time frame: 7 days
Extubation failure within 48 hours and 72 hours
Time frame: 48 hours and 72 hours
ICU length of stay post-extubation for medical reasons
Time frame: Up to 1 year
ICU re-admission rate within current hospitalization
Time frame: Up to 1 year
All-cause mortality: ICU, hospital, 28-days, 3 and 12 months
Time frame: 28-days, 3 and 12 months
Major adverse cardiac event
Time frame: 3 and 12 months
Quality of life of patients after ICU and hospital admission
Time frame: 3 and 12 months
Quality of life of patients after ICU and hospital admission
Time frame: 3 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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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.
H. Endeman, Dr. principal investigator
Erasmus Medical Center
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 Weaning Failure and Mechanical Ventilation, run by Henrik Endeman at 1 site in Netherlands.
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 3 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: finished, as of the sponsor's last update on 22 Jun 2026. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extubation failure (time frame: 7 days). The study lists 2 primary outcomes in all. 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 22 Jun 2026.