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 range1 Day – 5 Years
SexALL
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…
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.)