Bispectral Index (BIS) for Classification of Procalcitonin (PCT) Sepsis Grades in Critically Ill Patients With Sepsis (BIS6)
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)
Sponsor: Suez Canal University
This observational or N/A phase trial investigates Sepsis, Severe and is currently actively recruiting participants. Suez Canal University leads this study, which shows 14 recorded versions since 2014 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Study Description(click to expand)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.
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.
Status Flow
Change History
14 versions recorded-
Apr 28, 2026 — Present [daily]
Recruiting
Status: Unknown → Recruiting
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Jan 2026 — Apr 2026 [monthly]
Unknown
Status: Recruiting → Unknown
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Sep 2024 — Jan 2026 [monthly]
Recruiting
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Jul 2024 — Sep 2024 [monthly]
Recruiting
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Dec 2023 — Jul 2024 [monthly]
Recruiting
▶ Show 9 earlier versions
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Jun 2022 — Dec 2023 [monthly]
Recruiting
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Apr 2021 — Jun 2022 [monthly]
Recruiting
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Jan 2021 — Apr 2021 [monthly]
Recruiting
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Nov 2020 — Jan 2021 [monthly]
Recruiting
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Jul 2019 — Nov 2020 [monthly]
Recruiting
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Jun 2019 — Jul 2019 [monthly]
Recruiting
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Jun 2018 — Jun 2019 [monthly]
Recruiting
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Apr 2018 — Jun 2018 [monthly]
Recruiting
Phase: NA → None
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Aug 2017 — Apr 2018 [monthly]
Recruiting NA
First recorded
Jan 2014
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility 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.
Contact Information
- Suez Canal University
For direct contact, visit the study record on ClinicalTrials.gov .