Neuroimaging and Neuromonitoring in Critically Ill Children With Sepsis

Septic Shock Clinical Trial

Official title:

Neuroimaging and Neuromonitoring in Critically Ill Children With Sepsis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03055455
• Other study ID #: 16-012645
• Status: Completed
• Start date: February 1, 2017
• Est. completion date: September 27, 2019

Study information

• Verified date: April 2021
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 27, 2019
• Est. primary completion date: September 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Septic Shock
• Shock, Septic

Intervention

Diagnostic Test:
• MR imaging
Conventional structural imaging will be combined with advanced neuroimaging modalities to evaluate integrity of white matter tracts, regional brain perfusion, and the 3-dimensional volume of specific brain structures.

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI	Detection of signal abnormality on the patient's brain MRI scan.	2-10 days
Secondary	CAR	Trends in functionality of CAR over the first 10 days of severe sepsis. Identification of the optimal blood pressure range where CAR is most functional.	Daily for 10 days