Augmented Renal Clearance in Neurocritical Care

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
University of Alberta
Study ID
NCT07410624
Status
Recruiting
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Conditions

  • Augmented Renal Clearance (ARC)
  • Bacterial Meningitis
  • Intracerebral Hemorrhage
  • Ischemic Stroke
  • Status Epilepticus
  • Subarachnoid Hemorrhage, Aneurysmal
  • TBI (Traumatic Brain Injury)

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Oct 1, 2021
Status verified
Feb 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
512 participants (estimated)

Arms

  • Arm: Adult patients admitted to the Neuro-ICU with life-threatening neurological illness or injury
    Adult patients admitted to the Neuroscience Intensive Care Unit at any of the participating centers with life-threatening neurological illnesses (intracerebral hemorrhage, subarachnoid hemorrhage, ischemic stroke, status epilepticus, meningitis and traumatic brain injury).

Primary Outcome Measure

CrCl Measurements [ Time Frame: During hospital admission from enrolment for 10 days or until discharge from ICU, whichever comes first. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UK HealthCareLexingtonKentucky40536
Aaron Cook, PharmD, BCCCP, FKSHP, FCCP
[email protected]
859-257-8444
The Ohio State University Wexner Medical CenterColumbusOhio43210
Casey May, PharmD, BCCCP, FNCS
[email protected]
(614) 814-6519

Find similar trials in Lexington, KY

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
UK HealthCare· Lexington, KYThe Ohio State University Wexner Medical Center· Columbus, OH

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