An observational study in Critical Illness and Brain Injuries, sponsored by Centre Hospitalier Universitaire de Nīmes. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-31.
Sponsored by Centre Hospitalier Universitaire de Nīmes · Observational
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.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's planned enrollment of 140 is above the median of 100 across 690 observational studies indexed under Brain Injuries.
Browse Brain Injuries studies →Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.
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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
Exclusion Criteria:
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.
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.
Time frame: 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
Evolution of Augmented Renal Clearance
Assessment of urinary creatinine clearance based on urine collection (8, 12, or 24-hour collection depending on center practices).
Time frame: From date of inclusion until the date of discharge from intensive care, assessed up to 28 days
Evolution of plasma Beta-lactam Concentration
Monitoring of total plasma beta-lactam concentrations obtained through Therapeutic Drug Monitoring during the intensive care stay
Time frame: 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.
Time frame: 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.
Time frame: 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. * Clinical success is defined as the resolution of infectious symptoms present at the initiation of antibiotic therapy, allowing discontinuation of antibiotics at the end of the planned treatment duration. * Clinical failure is defined as the persistence or worsening of initial symptoms, the occurrence of superinfection (infection with newly identified pathogens), or recurrence (a new infectious episode with the same pathogen).
Time frame: From date of inclusion until the date of discharge from intensive care, assessed up to 28 days
Plan to share: Undecided
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Centre Hospitalier Universitaire de Nīmes