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Completed

NCT Number: NCT05637099

The Value of Repeated BIOMarker Measurements During an SBT to Predict EXtubation Failure in ICU Patients

The Value of Repeated BIOMarker Measurements During an SBT to Predict EXtubation Failure in Mechanically Ventilated ICU Patients

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Key information

Conditions

Weaning Failure Extubation Failure Mechanical Ventilation Spontaneous Breathing Trial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasmus MC

Rotterdam, South Holland, 3015 GD, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Extubation failure

    Time frame: 7 days

    The number of patients who were re-intubated within the next 7 days after extubation

  2. All-cause mortality

    Time frame: 7-days

    The number of patients who died within 7 days after extubation

Secondary outcomes

  1. Rescue non-invasive ventilation or high-flow nasal oxygen for post-extubation respiratory insufficiency

    Time frame: 7 days

    The number of patients with rescue non-invasive ventilation or high-flow nasal oxygen for post-extubation respiratory insufficiency

  2. Extubation failure within 48 hours and 72 hours

    Time frame: 48 hours and 72 hours

    The number of patients who re-intubated 48- and 72 hours after extubation

  3. ICU length of stay post-extubation for medical reasons

    Time frame: Up to 1 year

    The length of stay that patients were admitted in the ICU after extubation

  4. ICU re-admission rate within current hospitalization

    Time frame: Up to 1 year

    The number of patients who were readmitted in the ICU within the current hospitalization

  5. All-cause mortality: ICU, hospital, 28-days, 3 and 12 months

    Time frame: 28-days, 3 and 12 months

    The number of patients that died in the ICU, hospital, at 28-days, 3- and 12-months

  6. Major adverse cardiac event

    Time frame: 3 and 12 months

    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)

  7. Quality of life of patients after ICU and hospital admission

    Time frame: 3 and 12 months

    The quality of life will be measured using the RAND-36 (Units on a scale)

  8. Quality of life of patients after ICU and hospital admission

    Time frame: 3 and 12 months

    The quality of life will be measured using the EQ-5D questionnaire (Units on a scale)

Sponsors and collaborators

Lead sponsor

Henrik Endeman

Other

Collaborators

  • Roche Diagnostics GmbH

Registry information

Official study title

The Value of Repeated Biomarker Measurements During an SBT to Predict Extubation Failure in Mechanically Ventilated ICU Patients

Acronym: BIOMEXIC

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Dec 5, 2022
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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