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Clinical Trials/NCT03244293
NCT03244293
Recruiting
Not Applicable

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)

Suez Canal University1 site in 1 country20 target enrollmentJanuary 1, 2014
ConditionsSepsis, Severe

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sepsis, Severe
Sponsor
Suez Canal University
Enrollment
20
Locations
1
Primary Endpoint
Bispectral Index (BIS)-Electroencephalography (EEG) derived parameter correlated to the severity of Sepsis as indicated by Procalcitonin (PCT) biomarker.
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2014
End Date
December 1, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ashraf A. Dahaba

Principle Investigator

Suez Canal University

Eligibility Criteria

Inclusion Criteria

  • patients with sepsis
  • patients with sepsis

Exclusion Criteria

  • Patients who received drugs that would interfere with BIS monitoring

Outcomes

Primary Outcomes

Bispectral Index (BIS)-Electroencephalography (EEG) derived parameter correlated to the severity of Sepsis as indicated by Procalcitonin (PCT) biomarker.

Time Frame: 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)

Study Sites (1)

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