Sepsis, SevereBIS6NCT03244293
Bispectral Index (BIS) for Classification of Procalcitonin (PCT) Sepsis Grades in Critically Ill Patients With Sepsis
An observational study of Sepsis, Severe, run by Suez Canal University at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sepsis, Severe
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2014to 1 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Critical Care patients with all grades of Sepsis monitored with bispectral index
Who may be able to join
- patients with sepsis
Who cannot join
- Patients who received drugs that would interfere with BIS monitoring
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Dalian Medical University
Dalian, Dalian
Zhaoyang Xiao, MD
Ashraf Dahaba, MD, MSc
About this study
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)
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.
Read the 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.
- Conditions
- Sepsis, Severe
- Being tested
- no intervention
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Time point 1= On CCU admission, Time point 2= day 3 of CCU admission, Time point 3= on release from CCU.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start1 Jan 2014
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis, SevereStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraf A. Dahaba, Suez Canal University
- Investigators
- Ashraf Dahaba, MD, MSc, Principal investigator, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244293
- Sponsor's protocol ID
- MUGraz6
- Acronym
- BIS6
- Status last verified
- Apr 2026
- First submitted
- 2 Aug 2017
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03244293
- Acronym / sponsor ID
- BIS6 / MUGraz6
- Conditions
- Sepsis, Severe
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 9 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Critical Care patients with all grades of Sepsis monitored with bispectral index
Key inclusion criteria (1 listed)
- patients with sepsis
Key exclusion criteria (1 listed)
- Patients who received drugs that would interfere with BIS monitoring
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention | Other | – |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashraf Dahaba, MD, MSc principal investigator
Suez Canal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, Severe, run by Suez Canal University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashraf Dahaba (00436509006761, ashraf.dahaba@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.