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

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

Study Overview

• Status: Recruiting
• Conditions: Weaning Failure; Mechanical Ventilation; Extubation Failure; Spontaneous Breathing Trial

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, 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.

• Study Type: Observational
• Enrollment (Estimated): 266

Contacts and Locations

• Study Contact: Name: C. Groenland, Drs.; Phone Number: +31 6 29691879; Email: c.groenland@erasmusmc.nl
• Study Contact Backup: Name: V. Baggen, Dr.; Phone Number: +31 6 31016269; Email: v.baggen@erasmusmc.nl

Study Locations

• Netherlands
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3015 GD
      • Recruiting
      • Erasmus MC
      • Contact: C. Groenland, Drs.; Phone Number: +31629691879; Email: c.groenland@erasmusmc.nl
      • Contact: V. Baggen, Drs.; Phone Number: +31631016269; Email: v.baggen@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to the ICUs of the Erasmus MC and the Franciscus Gasthuis & Vlietland, who are mechanically ventilated for more than 48 hours.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extubation failure	The number of patients who were re-intubated within the next 7 days after extubation	7 days
All-cause mortality	The number of patients who died within 7 days after extubation	7-days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Henrik Endeman
• Collaborators: Roche Diagnostics
• Investigators: Principal Investigator: H. Endeman, Dr., Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: November 24, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: NL77372.078.21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No