RecruitingOBSERVATIONAL

Augmented Renal Clearance in Neurocritical Care

This study is for adults admitted to intensive care with serious brain conditions like stroke, brain injury, or infections. Sometimes, in these conditions, kidneys can work unusually fast – this is called Augmented Renal Clearance (ARC). When kidneys work too quickly, medicines, like those for seizures or infections, might be cleared from the body faster than expected. This could mean patients aren't getting enough medicine for it to work properly. Researchers want to understand how often ARC happens in these patients, how long it lasts, and what causes it. By collecting blood and urine samples, they hope to find better ways to detect ARC and figure out the best doses for important medicines. The goal is to improve how doctors care for patients with these life-threatening brain illnesses.

At a glance

Status

Recruiting

Sponsor

University of Alberta

Enrolment target

512

Start

01 Oct 2021

Estimated completion

30 Sep 2026

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

What is this study about?

Imagine your kidneys are like a filter, cleaning your blood and getting rid of waste products, including medicines. In some serious health situations, particularly after severe brain injuries, strokes, or infections affecting the brain, a person's kidneys might start working much faster than usual. This is called 'Augmented Renal Clearance' (ARC), which simply means 'increased kidney clearing'.

When kidneys are working overtime like this, they can clear medicines from the body very quickly. This can be a problem because if a patient is taking important medicines – like antibiotics for an infection or drugs to control seizures – those medicines might not stay in their system long enough or at a high enough level to be fully effective. Doctors often don't easily spot when a patient's kidneys are doing this, so they might accidentally be giving doses of medicine that are too low to work properly.

This research aims to bridge this gap in our understanding. The study will look at how common ARC is in patients with serious brain conditions in intensive care. By studying blood and urine samples, researchers hope to understand what causes ARC and how it affects important medicines. The ultimate goal is to help doctors more easily identify patients with ARC and provide clear guidance on how to adjust medicine doses so patients get the most effective treatment possible, improving their recovery and overall health.

Key takeaways

This study investigates how serious brain conditions might affect kidney function.
It focuses on 'Augmented Renal Clearance' (ARC), where kidneys work extra fast.
ARC can cause medicines to leave the body too quickly, making them less effective.
Researchers will collect blood and urine samples to understand ARC and its impact on medicine levels.
The goal is to improve medicine dosing for patients with serious brain conditions.
Participation involves routine sampling and does not involve new treatments.

Who may be eligible?

This study is looking for adults aged between 18 and 85 years old. You would need to be admitted to an intensive care unit (ICU) at one of the hospitals taking part in the study. You would also need to have a serious brain condition, such as a major stroke, a severe brain injury, uncontrolled seizures, or a brain infection like meningitis.

Before joining, you'll be asked to give your consent, meaning you agree to take part after understanding all the details. For practical reasons, you'd also need to have a special tube called a Foley catheter for collecting urine samples comfortably.

However, you wouldn't be able to join if you are in prison. Also, if your doctors expect you to be in the ICU for less than three days, you wouldn't be able to participate, as the study needs enough time to monitor your condition and take samples.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you aged between 18 and 85 years old?
Are you currently in an intensive care unit (ICU) for a serious brain condition (like stroke, brain injury, seizures, or infection)?
Do you have a Foley catheter in place (a small tube for urine collection)?
Is it expected you will be in the ICU for at least 3 days?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the doctors and nurses will collect urine and blood samples from you. These samples will help them understand how your kidneys are working and how certain medicines are being processed by your body. This will include tests to see if your kidneys are working extra fast (Augmented Renal Clearance, or ARC).

If you are receiving specific antibiotics or anti-seizure medications, additional blood samples may be taken to check the levels of these drugs in your system. This helps researchers understand if the medicines are at the right concentration to be effective, especially if you have ARC. The study does not involve any new or experimental medications; it focuses on understanding how your body handles the standard treatments you are already receiving. There are no extra visits or follow-up appointments required beyond your usual hospital care. The total duration of your participation would be for as long as you are in the intensive care unit where the samples are collected.

Potential risks and benefits

Taking part in this study might help doctors learn more about how kidneys affect medicine doses, which could lead to better treatment for future patients with serious brain conditions. Participants might not directly benefit from being in the study, as the findings will mainly help guide care for others in the future. The main risks involve a few extra blood and urine samples, which might cause some mild discomfort or bruising, similar to routine hospital tests. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care in any way.

Locations (3)

UK HealthCare
Verified postcode
Lexington, United States· Recruiting
The Ohio State University Wexner Medical Center
Verified postcode
Columbus, United States· Recruiting
University of Alberta Hospital
Verified postcode
Edmonton, Canada· Recruiting

Common questions

What is 'Augmented Renal Clearance'?

It means your kidneys are working faster than usual, clearing medicines from your body more quickly.

Why is this important?

If kidneys work too fast, medicines might not stay in your system long enough to work properly, leading to less effective treatment.

Will I receive new medicines?

No, this study focuses on how your body handles standard medicines you are already being given, not new ones.

What do I have to do if I join?

You would provide blood and urine samples, which are collected during your stay in intensive care.

Can I leave the study at any time?

Yes, you can withdraw at any point without it affecting your medical care.

How to find out more

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

smahmoud@ualberta.ca 780.492.5364 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.