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Neuroimaging and Neuromonitoring in Critically Ill Children With Sepsis

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ClinicalTrials.gov Identifier: NCT03055455
Recruitment Status : Recruiting
First Posted : February 16, 2017
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Tracking Information
First Submitted Date February 14, 2017
First Posted Date February 16, 2017
Last Update Posted Date July 30, 2020
Actual Study Start Date February 1, 2017
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 14, 2017)
MRI [ Time Frame: 2-10 days ]
Detection of signal abnormality on the patient's brain MRI scan.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 14, 2017)
CAR [ Time Frame: Daily for 10 days ]
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Neuroimaging and Neuromonitoring in Critically Ill Children With Sepsis
Official Title Neuroimaging and Neuromonitoring in Critically Ill Children With Sepsis
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Septic Shock
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.
Study Groups/Cohorts Sepsis
Children with severe sepsis or septic shock
Intervention: Diagnostic Test: MR imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 14, 2017)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Madeline Winters, BSN, RN 267-426-5788 wintersm@email.chop.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03055455
Other Study ID Numbers 16-012645
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Children's Hospital of Philadelphia
Study Sponsor Children's Hospital of Philadelphia
Collaborators Not Provided
Investigators
Principal Investigator: Matthew Kirschen, MD, PhD CHOP
PRS Account Children's Hospital of Philadelphia
Verification Date July 2020