Recruiting

Augmented Renal Clearance

Sponsor:

University of Alberta

Code:

NCT07410624

Conditions

TBI (Traumatic Brain Injury)

Status Epilepticus

Bacterial Meningitis

Augmented Renal Clearance (ARC)

Subarachnoid Hemorrhage, Aneurysmal

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

TBI (Traumatic Brain Injury)

Status Epilepticus

Bacterial Meningitis

Augmented Renal Clearance (ARC)

Subarachnoid Hemorrhage, Aneurysmal

Study ID

NCT07410624

Start date

Oct 1, 2021

Status verified date

Feb, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

512 participants

Anticipated

Interventions and Outcome Measures

Arms

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. ]
  • Drug Concentration Determination [ Time Frame: Sampling will occur during the hospital stay around a single drug dose after 2 to 3 days of consistent dosing to approach steady state concentration. ]

Central Contacts and Locations

Central contacts

Sherif H Mahmoud, BSc (Pharm), MSc, PhD, FNCS

780.492.5364smahmoud@ualberta.ca

Locations

UK HealthCare

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Aaron Cook, PharmD, BCCCP, FKSHP, FCCP

859-257-8444amcook0@email.uky.edu

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Casey May, PharmD, BCCCP, FNCS

(614) 814-6519may.645@osu.edu

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 2X8

Contacts

Sherif H Mahmoud, BSc (Pharm), MSc, PhD, FNCS

780-492-5364smahmoud@ualberta.ca

Principal Investigator:

Sherif Mahmoud, BSc (Pharm), MSc, PhD, FNCS

More Information

Sponsor

University of Alberta

Last update posted

Feb 18, 2026

Last verified

Feb, 2026

Keywords

  • traumatic brain injury
  • seizures
  • status epilepticus
  • bacterial meningitis
  • brain infections
  • neuro-ICU
  • augmented renal clearance (ARC)
  • augmented kidney function
  • creatinine clearance
  • neurological injury
  • TBI
  • ARC
  • subarachnoid hemorrhage
  • ischemic stroke
  • antimicrobials

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-02-18.