Sepsis-Associated EncephalopathyNCT06112119
Role of MSCT Volumetry in Assessment of Brain Atrophy in Septic Patients
An observational study of Sepsis-Associated Encephalopathy, run by Assiut University.
Trial summary
assessment of brain atrophy associated with septic ICU patients by using MSCT Volumetry Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Sepsis-Associated Encephalopathy
- What is being tested?
- MSCT
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- patients >16years old with sepsis associated with disturbance in conscious level admitted to ICU
Who cannot join
- Age< 16y Brain death Hematological disease Malignant disease Hypoxemia Error in automatic tissue classification Motion artifac
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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
- Conditions
- Sepsis-Associated Encephalopathy
- Being tested
- MSCT
- Medical subject headings
- Sepsis-Associated Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSCTDevice
Using Semi-automatic MSCT Volumetry in assessment of brain atrophy associated with septic ICU patients
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MSCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
- 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.
Measured: follow up through 10 days after admission in ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sepsis-Associated EncephalopathyStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Mohamed Abdelmoneim, Assiut University
- Investigators
- Nada mohamed abdelmoneim, Principal investigator, Assiut Universitysherif mohamed abdelaal, Study director, Assiut Universitysamy abdelaziz, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112119
- Sponsor's protocol ID
- sepsis and brain atrophy
- Status last verified
- Oct 2023
- First submitted
- 27 Oct 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
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.
PubMed 34844648
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Semi-automatic MSCT Volumetry in Assessment of Rapidly Progressive Brain Atrophy in Septic ICU Patients.
- ClinicalTrials.gov ID
- NCT06112119
- Acronym / sponsor ID
- sepsis and brain atrophy
- Conditions
- Sepsis-Associated Encephalopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 1 Nov 2023 (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.
assessment of brain atrophy associated with septic ICU patients by using MSCT Volumetry
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort | – | Device: MSCTpatients >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. |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- patients >16years old with sepsis associated with disturbance in conscious level admitted to ICU
Key exclusion criteria (1 listed)
- Age< 16y Brain death Hematological disease Malignant disease Hypoxemia Error in automatic tissue classification Motion artifac
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 |
|---|---|---|
| MSCTUsing Semi-automatic MSCT Volumetry in assessment of brain atrophy associated with septic ICU patients | Device | cohort |
Primary outcome
- 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Background: PubMed 34844648Nakae 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.
- retrospective study using semi automatic volumetryLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Nada mohamed abdelmoneim principal investigator
Assiut University
sherif mohamed abdelaal study director
Assiut University
samy abdelaziz study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis-Associated Encephalopathy, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nada mohamed abdelmoneim (01097151396, abdelmoneimnada44@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06112119, which also lists 1 linked publication.
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 1 Nov 2023.