NCT03244293

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
56mo left

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Jan 2014Dec 2030

Study Start

First participant enrolled

January 1, 2014

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 9, 2017

Completed
13.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

16.9 years

First QC Date

August 2, 2017

Last Update Submit

April 22, 2026

Conditions

Sepsis, Severe

Outcome Measures

Primary Outcomes (1)

  • 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)

    Time point 1= On CCU admission, Time point 2= day 3 of CCU admission, Time point 3= on release from CCU.

Interventions

no interventionOTHER

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • patients with sepsis

You may not qualify if:

  • Patients who received drugs that would interfere with BIS monitoring

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dalian Medical University

Dalian, Dalian, China

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ashraf Dahaba, MD, MSc

    Suez Canal University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashraf Dahaba

CONTACT

00436509006761ashraf.dahaba@medunigraz.at

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

August 2, 2017

First Posted

August 9, 2017

Study Start

January 1, 2014

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)