Bispectral Index (BIS) for Classification of Procalcitonin (PCT) Sepsis Grades in Critically Ill Patients With Sepsis (BIS6)

November 21, 2023 updated by: Ashraf A. Dahaba, Suez Canal University

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Dalian
      • Dalian, Dalian, China
        • Recruiting
        • Dalian Medical University
        • Contact:
          • Zhaoyang Xiao, MD
        • Principal Investigator:
          • Ashraf Dahaba, MD, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Critical Care patients with all grades of Sepsis monitored with bispectral index

Description

Inclusion Criteria: patients with sepsis

  • patients with sepsis

Exclusion Criteria:

  • Patients who received drugs that would interfere with BIS monitoring

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time point 1= On CCU admission, Time point 2= day 3 of CCU admission, Time point 3= on release from CCU.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suez Canal University

Investigators

  • Principal Investigator: Ashraf Dahaba, MD, MSc, Suez Canal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

August 2, 2017

First Submitted That Met QC Criteria

August 8, 2017

First Posted (Actual)

August 9, 2017

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUGraz6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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