Acute Exacerbation Copd
Conditions
Keywords
procalcitonin, mechanical ventilation, COPD exacerbation
Brief summary
This study assess whether a procalcitonin guided antibiotic therapy can reduce significantly unnecessary antibiotic prescription during severe exacerbation of COPD requiring mechanical ventilation without compromising patients' outcome. The first group of patients will receive systematically empiric antibiotic therapy and the second group will receive antibiotics only if procalcitonin value is at or greater than 0.25 ng/ml.
Detailed description
Recently, procalcitonin gained interest as the most reliable biomarker in predicting bacterial origin in low respiratory tract infections and sepsis. Procalcitonin was shown to be non-inferior to standard guidelines in guiding antibiotic therapy during COPD exacerbation, without worsening patients' outcomes, and with a significant reduction in antibiotic exposure. Its use to guide antibiotic treatment during COPD exacerbation may be more challenging because of the frequent colonization of the airways in patients with COPD, and thus it needs further evaluation. Additionally, until today, no interventional studies evaluating procalcitonin protocol have been conducted in ventilated COPD patients.
Interventions
DIAGNOSTIC_TESTprocalcitonin
procalcitonin value will be obtained within 24 hours after ICU admission in both groups and will be taken into account in the procalcitonin group only
Sponsors
University Hospital, Mahdia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients \> 40 years old who consent to the study protocol * COPD diagnosis based on GOLD guidelines
Exclusion criteria
* Patients who did not consent * Asthma * Malignancy * Immunocompromised * Survival for at least 1 year is unlikely * Patients already enrolled in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time to recovery | 28 days | defined by resolution of symptoms ( cough, sputum purulence and respiratory rate less than 25 breath per minute) and NIV withdrawal (normal pH for 24 consecutive hours after stopping NIV), for patients with home NIV investigators retain stabilization after returning to the same number of hours of NIV before current exacerbation and pH normalization for 24 consecutive hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital readmission for another exacerbation at day 90 | 90 days | another readmission for another episode of COPD exacerbation within 90 days after a first discharge |
| NIV failure | 28 days | clinical deterioration requiring invasive ventilation or death |
| Antibiotic exposure at day 90 | 90 days | number of days the patient received antibiotics for any infection within 90 days from the day of admission |
| Hospital length of stay (days) | 90 days | number of days spent in hospital during the index exacerbation |
| ICU mortality | 28 days | — |
| ICU length of say (days) | 90 days | number of days spent in the ICU during the index exacerbation |
Countries
Tunisia
Outcome results
None listed