Sepsis
Conditions
Interventions
The aim is to study the Sepsis-Associated Encephalopathy in Pediatrics (SAE-Ped), describing its main clinical, laboratory, electroencephalographic, imaging and prognostic findings.
We intend to incl
C10.228.140.807
Sponsors
Instituto D'Or de Pesquisa e Ensino
FIOCRUZ
Eligibility
Age
1 Months to 18 Years
Inclusion criteria
Inclusion criteria: Eligible, consecutive patients, whose parents agree with their participation, by signing the Free and Informed Consent Term (ICF) and, when relevant, the child or adolescent signs the Term of Assent (TA).
Exclusion criteria
Exclusion criteria: Refusal to sign the Informed Consent Form (ICF) and / or the Term of Assent (TA); Admission for palliative care; History of exposure to drugs, toxic substances, alcohol, industrial agents, heavy metals or any substance that is recognized may cause a change in the level of consciousness, acute disease in the central nervous system with repercussions on cognitive function, such as meningoencephalitis by any agent (viruses, fungi or bacteria), demyelinating syndromes, epilepsy; Primary immunodeficiency; Cancer under chemotherapy; Chronic use (over two weeks) of immunosuppressants in the past six months Use of corticosteroids in immunosuppressive doses in the past three months Use of neuroleptic medications with cognitive repercussions, as in the case of psychiatric illnesses; These conditions will be excluded to eliminate the influence of an inflammatory response not determined by sepsis at the level of biomarkers and to reduce confounding factors in the diagnosis of SAE-Ped.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical: Severity of clinical presentation (PIM2, PELOD, number of organ dysfunctions, Glasgow Coma Scale, FOUR scale, Cornell delirium scale, RASS sedation and agitation scale, State Behavioral Scale), ICU lethality, hospital lethality and lethality six months after hospital discharge, length of stay in the ICU and hospital. Laboratory: Serum levels of the NSE, S-100B and MCP1 biomarkers during the study period (first 7 days of hospitalization). Electroencephalography: EEG lasting 6 (six) hours during the study period, after the diagnosis of SAE-PED. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive screening: telephone contact with families at 3 (three) months after hospital discharge, when a cognitive function assessment questionnaire will be applied. | — |
Countries
Brazil
Contacts
Public ContactArnaldo Barbosa
Outcome results
None listed