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

NCT ID: NCT03244293

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-01

Study Completion Date

2025-12-01

Brief Summary

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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

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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.

Conditions

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Sepsis, Severe

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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no intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients with sepsis

Exclusion Criteria

* Patients who received drugs that would interfere with BIS monitoring
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suez Canal University

OTHER

Sponsor Role lead

Responsible Party

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Ashraf A. Dahaba

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ashraf Dahaba, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Suez Canal University

Locations

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Dalian Medical University

Dalian, Dalian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ashraf Dahaba

Role: CONTACT

00436509006761

Facility Contacts

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Zhaoyang Xiao, MD

Role: primary

Other Identifiers

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MUGraz6

Identifier Type: -

Identifier Source: org_study_id