Isoflurane-induced Neuroinflammation in Children With Hydrocephalus (NCT02512809) | Clinical Trial Compass
TerminatedPhase 3
Isoflurane-induced Neuroinflammation in Children With Hydrocephalus
Stopped: PI moving to another institution.
25 participantsStarted 2015-07
Plain-language summary
The investigators will quantify inflammatory biomarkers in cerebrospinal fluid (CSF) and serum of children with hydrocephalus who are undergoing ventriculoperitoneal shunt placement under isoflurane anesthesia.
Who can participate
Age range
1 Day – 5 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria (HC study patients):
* Pediatric patients, aged 6 months-less than 11 years, diagnosed with hydrocephalus undergoing a primary surgical (non-bedside) shunting procedure with general anesthesia.
* Participants must have a parent/guardian who is able to provide written informed consent in accordance with human investigation committee guidelines.
* The shunting procedure must be an initial VPS placement (not a VPS revision).
Inclusion Criteria (MRI with general anesthesia: peripheral blood patients; anesthesia but no surgery):
* Otherwise healthy pediatric patients, aged 6 months-less than 11 years, undergoing MRI with general anesthesia for evaluation of non-neurologic, non-inflammatory disease.
* Participants must have a parent/guardian who is able to provide written informed consent in accordance with IRB guidelines.
Exclusion Criteria (HC study patients):
* Any active infection or infection within the last 14 days.
* Treatment in the last 48 hours with non-steroidal anti-inflammatory (NSAID) or corticosteroid medications.
* Anticoagulant administration in the last 48 hours.
* Treatment with any drug known to induce or suppress inflammation.
* Clinically unstable patients.
* Patients that have an American Society of Anesthesiologists physical status ≥4 (severe, life-threatening disease).
* Infants born more than 4 weeks premature.
Exclusion Criteria (MRI with general anesthesia: peripheral blood patients; anesthesia but no surgery):
* Known central n…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Serum Cytokine Levels
Timeframe: On the day of surgery or MRI from start of procedure to discharge from PACU (approx. 1-7 hrs.)