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

Sponsor
Suez Canal University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03244293
Collaborator
(none)
20
Enrollment
1
Location
120
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: no intervention

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 Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
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)
Actual Study Start Date :
Jan 1, 2014
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Outcome Measures

Primary Outcome Measures

  1. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Inclusion Criteria: patients with sepsis

  • patients with sepsis
Exclusion Criteria:
  • Patients who received drugs that would interfere with BIS monitoring

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dalian Medical University Dalian Dalian China

Sponsors and Collaborators

  • Suez Canal University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ashraf A. Dahaba, Principle Investigator, Suez Canal University
ClinicalTrials.gov Identifier:
NCT03244293
Other Study ID Numbers:
  • MUGraz6
First Posted:
Aug 9, 2017
Last Update Posted:
May 5, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Sepsis
Toxemia

Study Results

No Results Posted as of May 5, 2022