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Critically ill patients admitted for acute brain injury are exposed to many heath-care associated infections such as ventilator associated pneumoniae (VAP). The PROHYVAP study, published in 2024 reported that a single dose of CEFTRIAXONE as an antibiotic prophylaxis could reduce the incidence of early VAP (VAP that occured between day 2 and day 7 of mechanical ventilation).
However, patients with acute brain injury also presented frequently augmented renal clearance (ARC), which could affect the pharmacokinetic and pharmacodynamic target attainment (PK/PD) of antibiotic prophylaxis.
This study aims to analyse the PK/PD target attainment after one dose of CEFTRIAXONE in critically ill patients with acute brain injury and to describe the effect of ARC on PK/PD target attainment during early VAP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Critically ill patients with acute brain injury | Patients with severe acute brain injury defined by a Glasgow coma scale < or = 8, admitted to the intensive care unit and needed invasive mechanical ventilation for at least 48 hours. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with PK/PD target attainment | Proportion of patients with serum concentrations of CEFTRIAXONE above the minimal inhibitory concentration (MIC) of 4 mg/mL (in case of undocumented VAP), or > 4 times the MIC of documented bacteria. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of the PK/PD target attainment on the incidence of early ventilator associated pneumoniae | Day 7 | |
| Association between augmented renal clearance and PK/PD target attainment | 24 hours | |
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Inclusion Criteria:
Exclusion Criteria:
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Patients admitted in intensive care unit for an acute brain injury caused by a traumatic brain injury or a vascular cerebral disease (ischemic stroke, subarachnoid hemorrhage, intracerebral hemorrhage) with a Glasgow coma scale < 12 and needed a mechanical ventilation for 48 hours or more, started in the first 12 hours.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maureen Steib, MD | Contact | +33 3 83 85 10 45 | m.steib@chru-nancy.fr |
| Name | Affiliation | Role |
|---|---|---|
| Emmanuel NOVY, MD,PhD | Central Hospital, Nancy, France | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Nancy - Hôpital Central | Nancy | Lorraine | 54000 | France | ||
| CHRU Nancy - Hopital Central |
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| Association between hyperbilirubinemia and PK/PD target attainment |
| 24 hours |
| Association between PK/PD target attainment and day 28 mortality | Day 28 |
| Association between PK/PD target attainment and ICU length of stay | 3 months |
| Incidence of multi drug resistance bacteria | Day 28 |
| Nancy |
| Meurthe-et-Moselle |
| 54000 |
| France |
|
| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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