No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 85
Sex
Any
Study type
Observational
Participants needed
512 (estimated)
Sponsor
University of Alberta · Other
Who this trial is looking for
This trial is looking for adults with life-threatening brain conditions to help understand how their kidneys affect medication dosing. Participants will need to be in the ICU and provide consent for urine collection to monitor kidney function.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 85 years old.
I am admitted to the ICU.
I have a diagnosis of SAH, TBI, ICH, meningitis, SE, or ischemic stroke.
I can provide informed consent.
I have a Foley catheter in place at the time of consent.
You may not be able to join if
I am currently incarcerated.
I will be in the ICU for less than 72 hours.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 appr…
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.
Trial Locations
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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. Incarce…
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)
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