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Bispectral Index (BIS) for Classification of Procalcitonin (PCT) Sepsis Grades in Critically Ill Patients With Sepsis

Sensitivity and Specificity of Bispectral Index (BIS) for Classification of Procalcitonin (PCT) Sepsis Grades in Critically Ill Patients With Sepsis, Severe Sepsis and Septic Shock and Multiple Organ Failure (MOF)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03244293
Acronym
BIS6
Enrollment
20
Registered
2017-08-09
Start date
2014-01-01
Completion date
2030-12-01
Last updated
2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis, Severe

Brief summary

To evaluate the discriminative power of BIS monitoring to classify the degree of mental state associated with the PCT graded sepsis cascade, and to assess its utility for monitoring the improvement or deterioration of sepsis.

Detailed description

To evaluate the discriminative power of BIS monitoring to classify the degree of mental state associated with the PCT graded sepsis cascade, and to assess its utility for monitoring the improvement or deterioration of sepsis. The primary endpoint of our study was to use an artefact-free 10-min mean BIS value to classify the degree of sepsis. As secondary endpoints, we correlated the mean BIS value to various mental state and sepsis parameters; PCT, C-reactive protein (CRP), Glasgow coma scale, and sequential organ failure assessment (SOFA) score. In a longitudinal study, patients' PCT sepsis grades were reassessed at a later time point and a second artefact-free 10-min mean BIS value was recorded to evaluate BIS evolution within the same patient.

Interventions

OTHERno intervention

Sponsors

Suez Canal University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

patients with sepsis * patients with sepsis

Exclusion criteria

* Patients who received drugs that would interfere with BIS monitoring

Design outcomes

Primary

MeasureTime frameDescription
Bispectral Index (BIS)-Electroencephalography (EEG) derived parameter correlated to the severity of Sepsis as indicated by Procalcitonin (PCT) biomarker.Time point 1= On CCU admission, Time point 2= day 3 of CCU admission, Time point 3= on release from CCU.Bispectral Index (BIS)-Electroencephalography (EEG) derived parameter (scale from 0=brain dead to 100= normal EEG) will be monitored and correlated to the severity of Sepsis as indicated by daily measured Procalcitonin (PCT) biomarker (\<0.5 micg/L =no sepsis up to 100 micg/L =Septic shock)

Countries

China

Contacts

CONTACTAshraf Dahaba
ashraf.dahaba@medunigraz.at00436509006761
PRINCIPAL_INVESTIGATORAshraf Dahaba, MD, MSc

Suez Canal University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 24, 2026