Septic ShockNCT03055455
Neuroimaging and Neuromonitoring in Critically Ill Children With Sepsis
An observational study of Septic Shock, run by Children's Hospital of Philadelphia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- MR imaging
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 27 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
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
- Being tested
- MR imaging
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR imagingDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis | Children with severe sepsis or septic shock Receives: Diagnostic Test: MR imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI
Detection of signal abnormality on the patient's brain MRI scan.
Measured: 2-10 days
Secondary outcomes (1)
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.
Measured: Daily for 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start1 Feb 2017
- Primary completion27 Sep 2019
- Study completion27 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Kirschen, MD, PhD, Principal investigator, CHOP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055455
- Sponsor's protocol ID
- 16-012645
- Status last verified
- Apr 2021
- First submitted
- 14 Feb 2017
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging and Neuromonitoring in Critically Ill Children With Sepsis
- ClinicalTrials.gov ID
- NCT03055455
- Acronym / sponsor ID
- 16-012645
- Conditions
- Septic Shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 27 Sep 2019 (actual)
- Study completion
- 27 Sep 2019 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sepsis | – | Diagnostic Test: MR imagingChildren with severe sepsis or septic shock |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR imagingConventional 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. | Diagnostic test | Sepsis |
Primary outcome
MRI
Time frame: 2-10 days
Detection of signal abnormality on the patient's brain MRI scan.
1 secondary outcome
CAR
Time frame: Daily for 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
- Individual participant dataSharing planned: No
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Kirschen, MD, PhD principal investigator
CHOP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI (time frame: 2-10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2021.