Neuroimaging and Neuromonitoring in Critically Ill Children With Sepsis
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 3 - 18 |
| Updated: | 3/28/2019 |
| Start Date: | February 1, 2017 |
| End Date: | December 31, 2020 |
| Contact: | Madeline Winters, BSN, RN |
| Email: | wintersm@email.chop.edu |
| Phone: | 267-426-5788 |
In critically ill children with severe sepsis, neurophysiologic derangements often proceed
undetected and can lead to irreversible brain injury causing neurocognitive and behavioral
deficits. The etiology of these impairments is unclear, however, it is likely that some of
this neural injury is preventable. The overarching goal for this study is to show that acute
acquired structural and microstructural brain injury occurs in critically ill children with
severe sepsis, and that this injury is related to neuropsychological deficits and impaired
cerebral autoregulation (CAR). Subjects will complete Magnetic resonance (MR) imaging within
2-10 days of recognition of their severe sepsis. Subjects will undergo serial interrogation
of CAR for up to 10 days. CAR will be determined by the correlation of arterial blood
pressure with middle cerebral artery flow velocity measured by transcranial doppler
ultrasonography and cerebral oximetry derived from near-infrared spectroscopy. Subjects will
also participate in a neuropsychological evaluation 6 months after enrollment to evaluate
multiple domains of behavior and cognition.
undetected and can lead to irreversible brain injury causing neurocognitive and behavioral
deficits. The etiology of these impairments is unclear, however, it is likely that some of
this neural injury is preventable. The overarching goal for this study is to show that acute
acquired structural and microstructural brain injury occurs in critically ill children with
severe sepsis, and that this injury is related to neuropsychological deficits and impaired
cerebral autoregulation (CAR). Subjects will complete Magnetic resonance (MR) imaging within
2-10 days of recognition of their severe sepsis. Subjects will undergo serial interrogation
of CAR for up to 10 days. CAR will be determined by the correlation of arterial blood
pressure with middle cerebral artery flow velocity measured by transcranial doppler
ultrasonography and cerebral oximetry derived from near-infrared spectroscopy. Subjects will
also participate in a neuropsychological evaluation 6 months after enrollment to evaluate
multiple domains of behavior and cognition.
Inclusion Criteria:
- Admission to the Children's Hospital of Philadelphia (CHOP) pediatric intensive care
unit (PICU)
- Males or females ages ≥ 3.5 years and ≤ 18 years on day of sepsis recognition
- Meet published consensus criteria for severe sepsis or septic shock: a) ≥ 2 systemic
inflammatory response syndrome criteria, b) suspected (based on attending physician)
or confirmed systemic infection, and c) ≥ 2 or more organ system dysfunctions (severe
sepsis) or cardiovascular dysfunction (septic shock).
- An indwelling arterial catheter.
- Parental/guardian permission (informed consent).
- The patient and parent/guardian are fluent in English.
Exclusion Criteria:
- History of neurologic disorder including (hypoxic ischemic injury, traumatic brain
injury, epileptic encephalopathy, neurodevelopmental, neurometabolic or neurogenetic
conditions, and structural brain anomalies).
- History of cancer or undergoing treatment for cancer.
- Meningitis or encephalitis as source of sepsis.
- Congenital heart disease.
- History of cardiac arrest.
- History of extracorporeal membrane oxygenation (ECMO) cannulation.
- Patients with contraindications to MR scanning.
- Pregnant or lactating females.
- Parents/guardians or subjects who, in the opinion of the Investigator, may be
non-compliant with study schedules or procedures.
- Previous enrollment in this study.
We found this trial at
1
site
South 34th Street
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
215-590-1000
Phone: 267-426-5788
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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