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

NCT ID: NCT05637099

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

266 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-01

Study Completion Date

2026-05-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Weaning Failure Mechanical Ventilation Spontaneous Breathing Trial Extubation Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roche Diagnostics GmbH

INDUSTRY

Sponsor Role collaborator

Henrik Endeman

OTHER

Sponsor Role lead

Responsible Party

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Henrik Endeman

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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H. Endeman, Dr.

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

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Erasmus MC

Rotterdam, South Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL77372.078.21

Identifier Type: -

Identifier Source: org_study_id