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Augmented Renal Clearance (ARC), defined as a supraphysiological increase in renal function, is frequently observed in critically ill patients, particularly those with acute brain injury. ARC complicates the management of renally eliminated drugs, specifically beta-lactam antibiotics, by enhancing drug clearance and thereby increasing the risk of underdosing and therapeutic failure. Although pharmacological therapeutic drug monitoring (TDM) is recommended to optimize dosing, it remains limited by issues of accessibility, highlighting the need for alternative approaches to identify at-risk patients and adjust dosing based on renal function.
Early identification of patients at risk for subtherapeutic beta-lactam plasma concentrations could enable timely dose adjustments. A combined assessment of renal function and beta-lactam TDM could enhance our understanding of the kinetics of both parameters. These data may support the development of predictive models capable of proposing individualized dosing regimens based on renal function.
Optimizing beta-lactam plasma concentrations in this patient population could improve infection management and potentially enhance clinical outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BETALACTAM Treated Patients | Adult patients (≥18 years) admitted to intensive care for acute brain injury, presenting with an infectious episode, documented augmented renal clearance (as assessed by urinary creatinine clearance), and receiving treatment with beta-lactam antibiotics. |
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma betalactam underdosing | Development of a predictive model for plasma beta-lactam underdosing in critically ill patients with acute brain injury and renal hyperclearance, receiving beta-lactam therapy for an ongoing infectious episode. Plasma beta-lactam concentrations will be measured 24 hours after initiation of antibiotic therapy, and subsequently every 48 hours, or in cases of underdosing, overdosing, antibiotic switch, or significant changes in renal function. | 24 hours after the start of antibiotic therapy, and repeated every 48 hours or in the event of underdosing, overdosing, change of molecule or significant variation in renal function, assessed until the antibiotic therapy is stopped, for up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of Augmented Renal Clearance | Assessment of urinary creatinine clearance based on urine collection (8, 12, or 24-hour collection depending on center practices). | From date of inclusion until the date of discharge from intensive care, assessed up to 28 days |
| Evolution of plasma Beta-lactam Concentration |
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Inclusion Criteria:
Exclusion Criteria:
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The population studied included patients admitted to the intensive care unit with acute brain injury (of traumatic, vascular, infectious or immunological origin), presenting a profile of HCR and receiving antibiotic treatment with betalactam
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claire ROGER, MD, pHD | Contact | +33 466683331 | claire.roger@chu-nimes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nîmes - Hôpital Universitaire Carémeau | Recruiting | Nîmes | 30029 | France |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
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Monitoring of total plasma beta-lactam concentrations obtained through Therapeutic Drug Monitoring during the intensive care stay |
| From date of inclusion until the date of discharge from intensive care, assessed up to 28 days |
| Relationship Between Plasma Underdosing Intensity and Level of Augmented Renal Clearance (ARC) | Characterization of the intensity of plasma beta-lactam underdosing for each antibiotic molecule relative to the degree of ARC. | From date of inclusion until the date of discharge from intensive care, assessed up to 28 days |
| Beta-lactam Dosing According to Augmented Renal Clearance Level. | Development of a dosing nomogram for beta-lactam antibiotics tailored to the degree of ARC. | From date of inclusion until the date of discharge from intensive care, assessed up to 28 days |
| Clinical outcome | Assessment of clinical outcomes based on rates of clinical success and failure.
| From date of inclusion until the date of discharge from intensive care, assessed up to 28 days |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |