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

Sepsis, Severe Clinical Trial

— BIS6  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03244293
• Other study ID #: MUGraz6
• Status: Recruiting
• Start date: January 1, 2014
• Est. completion date: December 1, 2025

Study information

• Verified date: November 2023
• Source: Suez Canal University
• Contact: Ashraf Dahaba
• Phone: 00436509006761
• Email: ashraf.dahaba[@]medunigraz.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria: patients with sepsis

• patients with sepsis

Exclusion Criteria:

• Patients who received drugs that would interfere with BIS monitoring

Related Conditions & MeSH terms

• Sepsis
• Sepsis, Severe
• Toxemia

Intervention

Other:
• no intervention

Locations

Country	Name	City	State
China	Dalian Medical University	Dalian	Dalian

Sponsors (1)

Lead Sponsor	Collaborator
Suez Canal University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bispectral Index (BIS)-Electroencephalography (EEG) derived parameter correlated to the severity of Sepsis as indicated by Procalcitonin (PCT) biomarker.	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)	Time point 1= On CCU admission, Time point 2= day 3 of CCU admission, Time point 3= on release from CCU.