Neuroimaging and Neuromonitoring in Critically Ill Children With Sepsis

NCT03055455 | Completed

• 1 other identifier: 16-012645
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• MRI

  Detection of signal abnormality on the patient's brain MRI scan.

  2-10 days

Secondary Outcomes (1)

• CAR

  Daily for 10 days

Study Arms (1)

Sepsis

Children with severe sepsis or septic shock

Diagnostic Test: MR imaging

Interventions

MR imaging DIAGNOSTIC_TEST

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.

Sepsis

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children admitted to the pediatric intensive care unit (PICU) at the Children's Hospital of Philadelphia (CHOP) with severe sepsis from an extracranial source and have no history of a preexisting underlying a neurologic disorder.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Matthew Kirschen, MD, PhD

  CHOP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 16, 2017
• Study Start: February 1, 2017
• Primary Completion: September 27, 2019
• Study Completion: September 27, 2019
• Last Updated: April 12, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)