NCT07410624 Augmented Renal Clearance in Neurocritical Care
| NCT ID | NCT07410624 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alberta |
| Condition | TBI (Traumatic Brain Injury) |
| Study Type | OBSERVATIONAL |
| Enrollment | 512 participants |
| Start Date | 2021-10-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 512 participants in total. It began in 2021-10-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Stroke, severe brain injury, uncontrolled seizures and brain infections are the most common life-threatening neurological illnesses in the world with an estimated combined annual hospital management cost of up to 44 billion dollars. Seizures and infections are common complications following acute neurological illnesses and contribute significantly to poor outcomes if not promptly treated with appropriately dosed anti-seizure medications and antibiotics, respectively. Limited research suggested that many of those patients present with a phenomenon called augmented renal clearance (ARC) or, in other words, enhanced kidney function. ARC may have a significant influence on how medications are removed from the body potentially resulting in insufficient doses and treatment failure. Therefore, patients with ARC require higher medication doses; however, ARC is largely undetected using kidney assessment methods currently used in practice. In addition, it is not clear how medications should be dosed in those with ARC. The majority of ARC research has not focused on patients with life-threatening neurological illnesses. Thus, clinicians are likely under-dosing vital medications in those patients, and completely unaware. There is an immediate need to address the gap in knowledge. Therefore, this research aims to characterize the phenomenon of ARC in patients with life-threatening neurological illnesses through identifying the frequency, duration, contributing factors and clinical impact of ARC. Adult patients admitted to the neurosciences intensive care unit for life-threatening neurological illnesses will be enrolled in the study. Urine and blood samples wil be collected from participants to determine the presence of ARC and identify its contributing factors. In addition, blood samples will be collected from participants treated with select antibiotics and anti-seizure medications to determine their concentration and propose dose adjustment in those with ARC. This research is expected to improve the care of patients with life-threatening neurological illnesses through efficient identification and monitoring of patients exhibiting ARC facilitating timely medication dosage optimization. Furthermore, recommendations of optimal doses of commonly used medications in patients with ARC would improve the likelihood of treatment success with potential to improve patients' health and wellbeing.
Eligibility 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)
Contact & Investigator
Sherif H Mahmoud, BSc (Pharm), MSc, PhD, FNCS
PRINCIPAL INVESTIGATOR
University of Alberta
Frequently Asked Questions
Who can join the NCT07410624 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying TBI (Traumatic Brain Injury). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07410624 currently recruiting?
Yes, NCT07410624 is actively recruiting participants. Contact the research team at smahmoud@ualberta.ca for enrollment information.
Where is the NCT07410624 trial being conducted?
This trial is being conducted at Lexington, United States, Columbus, United States, Edmonton, Canada.
Who is sponsoring the NCT07410624 clinical trial?
NCT07410624 is sponsored by University of Alberta. The principal investigator is Sherif H Mahmoud, BSc (Pharm), MSc, PhD, FNCS at University of Alberta. The trial plans to enroll 512 participants.