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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05637099
Other study ID # NL77372.078.21
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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