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Augmented Renal Clearance in Neurocritical Care Population: A Prospective Multicenter Study

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Age 18-85 years

• Admitted to ICU at one of the participating sites

• Diagnosis: SAH, TBI, ICH, meningitis, SE or ischemic stroke

• Provision of informed consent

• Foley catheter in place at time of consent (to facilitate urine collection)

Locations
United States
Kentucky
UK HealthCare
RECRUITING
Lexington
Ohio
The Ohio State University Wexner Medical Center
RECRUITING
Columbus
Other Locations
Canada
University of Alberta Hospital
RECRUITING
Edmonton
Contact Information
Primary
Sherif H Mahmoud, BSc (Pharm), MSc, PhD, FNCS
smahmoud@ualberta.ca
780.492.5364
Time Frame
Start Date: 2021-10-01
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 512
Treatments
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).
Sponsors
Collaborators: University of Kentucky, Ohio State University
Leads: University of Alberta

This content was sourced from clinicaltrials.gov