Role of MSCT Volumetry in Assessment of Brain Atrophy in Septic Patients

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06112119

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Sepsis-Associated Encephalopathy	Device: MSCT

Detailed Description

Sepsis is the leading cause of admission to ICU , the number of patients who survive and discharge from ICU has also increased due to technological advances in ICU however quality of life of these patients after ICU discharge is lower than that of healthy people of a similar age, in particular Sepsis associated encephalopathy associated with brain dysfunction.

We hypothesized that brain damage including brain volume reduction that ocurre in acute phase of Sepsis using CT scan and there finding " relationship to risk factor and outcome".

We compared head CT finding at time of admission with those obtained during the course of the treatment

Study Design

Study Type:

Observational

Anticipated Enrollment :

55 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Role of Semi-automatic MSCT Volumetry in Assessment of Rapidly Progressive Brain Atrophy in Septic ICU Patients.

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Dec 30, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

- 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. [follow up through 10 days after admission in ICU]
- 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

Principal Investigator: Nada mohamed abdelmoneim, Assiut University
Study Director: sherif mohamed abdelaal, Assiut University
Study Director: samy abdelaziz, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

retrospective study using semi automatic volumetry

Publications

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.

Responsible Party:

Nada Mohamed Abdelmoneim, Assistant Lecturer, Assiut University

ClinicalTrials.gov Identifier:

NCT06112119

Other Study ID Numbers:

sepsis and brain atrophy

First Posted:

Nov 1, 2023

Last Update Posted:

Nov 1, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Additional relevant MeSH terms:

Brain Diseases

Sepsis-Associated Encephalopathy

Atrophy

Study Results

No Results Posted as of Nov 1, 2023