Augmented kidney clearance in neurocritical care
Augmented Renal Clearance in Neurocritical Care Population: A Prospective Multicenter Study
University of Alberta · NCT07410624
This project will test whether adults in the neuro-ICU with severe brain injury, stroke, seizures, or brain infections have faster kidney clearance (ARC) that can lower antiseizure and antibiotic drug levels.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 512 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Alberta (other) |
| Locations | 3 sites (Lexington, Kentucky and 2 other locations) |
| Trial ID | NCT07410624 on ClinicalTrials.gov |
What this trial studies
Severe brain injuries, strokes, status epilepticus and meningitis are often complicated by augmented renal clearance (ARC), where the kidneys clear drugs faster than expected. This multicenter observational study will enroll adults in participating neurocritical care ICUs and use timed urine collections (via Foley catheter) and blood sampling to measure creatinine clearance and drug exposures. Measured creatinine clearance (with ARC defined as CrCl >130 ml/min/1.73 m2) will be compared to common estimated equations while antiseizure and antimicrobial dosing and clinical outcomes are recorded. The overall aim is to characterize how common ARC is in these neurocritical populations and to generate guidance for clinicians on identification and monitoring.
Who should consider this trial
Good fit: Adults aged 18–85 admitted to a participating ICU with SAH, TBI, ICH, meningitis, status epilepticus or ischemic stroke who have a Foley catheter in place are ideal candidates.
Not a fit: Patients with anticipated ICU stays under 72 hours, those without a Foley catheter, incarcerated individuals, or patients with established low kidney function are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, the results could help clinicians detect ARC and adjust drug doses to avoid under-treatment of seizures and infections.
How similar studies have performed: Prior studies outside neurocritical care have shown ARC can reduce concentrations of renally cleared drugs, but ARC in neurocritical care patients remains under-studied and lacks clear dosing recommendations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18-85 years 2. Admitted to ICU at one of the participating sites 3. Diagnosis: SAH, TBI, ICH, meningitis, SE or ischemic stroke 4. Provision of informed consent 5. Foley catheter in place at time of consent (to facilitate urine collection) Exclusion Criteria: 1. Incarceration 2. Anticipated ICU length of stay is \< 72 hours (insufficient time for monitoring)
Where this trial is running
Lexington, Kentucky and 2 other locations
- UK HealthCare — Lexington, Kentucky, United States (RECRUITING)
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (RECRUITING)
- University of Alberta Hospital — Edmonton, Alberta, Canada (RECRUITING)
Study contacts
- Principal investigator: Sherif H Mahmoud, BSc (Pharm), MSc, PhD, FNCS — University of Alberta
- Study coordinator: Sherif H Mahmoud, BSc (Pharm), MSc, PhD, FNCS
- Email: smahmoud@ualberta.ca
- Phone: 780.492.5364
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: TBI, Status Epilepticus, Bacterial Meningitis, Augmented Renal Clearance, Subarachnoid Hemorrhage, Aneurysmal, Ischemic Stroke, Intracerebral Hemorrhage, traumatic brain injury