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

Mechanical Ventilation Clinical Trial

— BIOMEXIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05637099
• Other study ID #: NL77372.078.21
• Status: Recruiting
• Start date: August 1, 2022
• Est. completion date: August 1, 2025

Study information

• Verified date: November 2023
• Source: Erasmus Medical Center
• Contact: C. Groenland, Drs.
• Phone: +31 6 29691879
• Email: c.groenland[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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, IL-10, PCT, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 266
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Extubation Failure
• Mechanical Ventilation
• Respiratory Aspiration
• Spontaneous Breathing Trial
• Weaning Failure

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam	Zuid-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Henrik Endeman	Roche Diagnostics

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extubation failure	The number of patients who were re-intubated within the next 7 days after extubation	7 days
Primary	All-cause mortality	The number of patients who died within 7 days after extubation	7-days
Secondary	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	7 days
Secondary	Extubation failure within 48 hours and 72 hours	The number of patients who re-intubated 48- and 72 hours after extubation	48 hours and 72 hours
Secondary	ICU length of stay post-extubation for medical reasons	The length of stay that patients were admitted in the ICU after extubation	Up to 1 year
Secondary	ICU re-admission rate within current hospitalization	The number of patients who were readmitted in the ICU within the current hospitalization	Up to 1 year
Secondary	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	28-days, 3 and 12 months
Secondary	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)	3 and 12 months
Secondary	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)	3 and 12 months
Secondary	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)	3 and 12 months