NCT06112119

Brief Summary

assessment of brain atrophy associated with septic ICU patients by using MSCT Volumetry

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2023

Status
unknown

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

First Submitted

Initial submission to the registry

October 27, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

October 27, 2023

Last Update Submit

October 27, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • - Correlation between sepsis and brain volume reduction . - Determine the role of the CT scan in assess brain volume in acute phase of sepsis and it,s influences in improvement activities of daily living.

    \- Determine the role of the CT scan in assess brain volume in acute phase of sepsis and it,s influences in improvement activities of daily living after discharge from ICU.

    follow up through 10 days after admission in ICU

Study Arms (1)

cohort

patients \>16y with sepsis associated with disturbance in conscious level, the first braun CT scan will be routinely performed on admission, the second further brain CT Scan will be obtained whenever prolonged disturbance of consciousness will be detected.

Device: MSCT

Interventions

MSCTDEVICE

Using Semi-automatic MSCT Volumetry in assessment of brain atrophy associated with septic ICU patients

cohort

Eligibility Criteria

Age16 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

All the patients will be included within ehs inclusion criteria after giving informed consent from patients or from the hospital board to review patients' medical records, it will include: * Full history taking. * Clinically provisinal diagnosis . * Blood and bacterial culture was performed at the time of admission for all patients . * Firstly All studies were performed by using a CT device. CT scans measuring brain volume using BCR which is the width between anterior horn of the bilateral lateral ventricle divided by that of the cerebrum at the same height at the caudate nucleus that measuring in particular frontal lobe volume . * Also using Evan index which is the width between anterior horn of the bilateral lateral ventricles divided by cranial lumen at the same height . * When increase BCR and EI ,decrease in brain volume ocurr.

You may qualify if:

  • patients \>16years old with sepsis associated with disturbance in conscious level admitted to ICU

You may not qualify if:

  • Age\< 16y Brain death Hematological disease Malignant disease Hypoxemia Error in automatic tissue classification Motion artifac

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Nakae R, Sekine T, Tagami T, Murai Y, Kodani E, Warnock G, Sato H, Morita A, Yokota H, Yokobori S. Rapidly progressive brain atrophy in septic ICU patients: a retrospective descriptive study using semiautomatic CT volumetry. Crit Care. 2021 Nov 29;25(1):411. doi: 10.1186/s13054-021-03828-7.

    PMID: 34844648BACKGROUND

Related Links

MeSH Terms

Conditions

Sepsis-Associated Encephalopathy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Nada mohamed abdelmoneim

    Assiut University

    PRINCIPAL INVESTIGATOR
  • sherif mohamed abdelaal

    Assiut University

    STUDY DIRECTOR
  • samy abdelaziz

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Nada mohamed abdelmoneim

CONTACT

sherif mohamed abdelaal

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

October 27, 2023

First Posted

November 1, 2023

Study Start

November 1, 2023

Primary Completion

November 1, 2024

Study Completion

December 30, 2024

Last Updated

November 1, 2023

Record last verified: 2023-10