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

October 27, 2023 updated by: Nada Mohamed Abdelmoneim, Assiut University

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

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

Study Overview

Status

Not yet recruiting

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
- 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.
Time Frame: 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.
follow up through 10 days after admission in ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

October 27, 2023

First Submitted That Met QC Criteria

October 27, 2023

First Posted (Actual)

November 1, 2023

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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