Fluid BalanceCAI for fluidsNCT06940258
Caval Aorta Index for Fluid Optimization in Traumatic Brain Injury
A study testing ultrasound measurement of caval aorta index in people with Fluid Balance, run by Mansoura University at 1 site in Egypt.
Trial summary
Traumatic brain injury is a leading cause of death and disability in trauma patients. As the primary injury cannot be reversed; management strategies must focus on preventing secondary injury by avoiding hypotension and hypoxia besides, maintaining appropriate cerebral perfusion pressure, which is a surrogate for… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Fluid Balance
- What is being tested?
- ultrasound measurement of caval aorta index
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to 30 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Traumatic brain injury diagnosed by computed tomography scan Glasgow coma score ≥ 4
Who cannot join
- Inability to get consent. Pregnant and lactating women Traumatic subarachnoid hemorrhage Spinal cord injury Increased intra-abdominal pressure Abdominal aortic aneurysm Inferior vena cava (IVC) thrombus Portal hypertension Acute corpulmonale Congestive heart failure chronic hemodialysis Surgical intervention other than neurological one within the first 7 days Mechanical ventilation need during first 7 days Cardiac arrest during the first 7 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mai Ibrahim Sobh, MBBS contact
About this study
Official title: Efficacy of Caval Aorta Index for Fluid Optimization in Critically Ill Patients With Traumatic Brain Injury
Traumatic brain injury is a leading cause of death and disability in trauma patients. As the primary injury cannot be reversed; management strategies must focus on preventing secondary injury by avoiding hypotension and hypoxia besides, maintaining appropriate cerebral perfusion pressure, which is a surrogate for cerebral blood flow.
Read the detailed description
The caval aorta index is an ultrasound element, relatively new, used to assess volume status. Technically, the sonographic assessment of the inferior vena cava /aorta diameter ratio is an easy test to perform and can be performed effectively by doctors who are not experienced in the field of sonography (Kusumastuti et al .2021).
In this study; the caval aorta index will be used to guide fluid dosage in critically ill patients with traumatic brain injury.
- Conditions
- Fluid Balance
- Being tested
- ultrasound measurement of caval aorta index, control group
- Keywords
- caval aorta index, traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound measurement of caval aorta indexProcedure or surgery
ultrasound measurement of caval aorta index
control groupOther
fixed fluid prescription
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Not described Receives: Other: control group |
| ultrasound-guided caval-aorta index group | Experimental | Not described Receives: Procedure: ultrasound measurement of caval aorta index |
What is being measured
The primary outcome is the main question the study is designed to answer.
fluid balance
the difference between fluid input and fluid loss
Measured: after 96 hours from the admission
Secondary outcomes (6)
Urine output
mL
Measured: Daily for 7 weeks
Central Venous Pressure (CVP) measurements
cm H2O
Measured: Daily every 6 hours for 7 days
Frequency and duration of hypotension
systolic blood pressure less than 90 mmhg
Measured: within first 7 days
Glasgow Coma Scale
range from 3-to-15
Measured: daily within first 7 days
Central capillary refill
seconds
Measured: Daily for 7 days
incidence of pulmonary edema
new B-lines in lung Ultrasound
Measured: Daily within first 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start1 Jun 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid BalanceStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After enrollment, patients will be randomly allocated using block into two groups of 46 patients in each group; ultrasound-guided fluid management (US group) or standard care (C group)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maha abou-zeid, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940258
- Sponsor's protocol ID
- Caval aorta index
- Acronym
- CAI for fluids
- Status last verified
- Oct 2026
- First submitted
- 15 Apr 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Caval Aorta Index for Fluid Optimization in Critically Ill Patients With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06940258
- Acronym / sponsor ID
- CAI for fluids / Caval aorta index
- Conditions
- Fluid Balance
- Keywords
- caval aorta index, traumatic brain injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 23 Apr 2025 (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.
Traumatic brain injury is a leading cause of death and disability in trauma patients. As the primary injury cannot be reversed; management strategies must focus on preventing secondary injury by avoiding hypotension and hypoxia besides, maintaining appropriate cerebral perfusion pressure, which is a surrogate for cerebral blood flow.
Detailed description
The caval aorta index is an ultrasound element, relatively new, used to assess volume status. Technically, the sonographic assessment of the inferior vena cava /aorta diameter ratio is an easy test to perform and can be performed effectively by doctors who are not experienced in the field of sonography (Kusumastuti et al .2021).
In this study; the caval aorta index will be used to guide fluid dosage in critically ill patients with traumatic brain injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- After enrollment, patients will be randomly allocated using block into two groups of 46 patients in each group; ultrasound-guided fluid management (US group) or standard care (C group)
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: control group |
| ultrasound-guided caval-aorta index group | Experimental | Procedure: ultrasound measurement of caval aorta index |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Traumatic brain injury diagnosed by computed tomography scan Glasgow coma score ≥ 4
Key exclusion criteria (1 listed)
- Inability to get consent. Pregnant and lactating women Traumatic subarachnoid hemorrhage Spinal cord injury Increased intra-abdominal pressure Abdominal aortic aneurysm Inferior vena cava (IVC) thrombus Portal hypertension Acute corpulmonale Congestive heart failure chronic hemodialysis Surgical intervention other than neurological one within the first 7 days Mechanical ventilation need during first 7 days Cardiac arrest during the first 7 days
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 |
|---|---|---|
| ultrasound measurement of caval aorta indexultrasound measurement of caval aorta index | Procedure or surgery | ultrasound-guided caval-aorta index group |
| control groupfixed fluid prescription | Other | Control group |
Primary outcome
fluid balance
Time frame: after 96 hours from the admission
the difference between fluid input and fluid loss
6 secondary outcomes
Urine output
Time frame: Daily for 7 weeks
Central Venous Pressure (CVP) measurements
Time frame: Daily every 6 hours for 7 days
Frequency and duration of hypotension
Time frame: within first 7 days
Glasgow Coma Scale
Time frame: daily within first 7 days
Central capillary refill
Time frame: Daily for 7 days
incidence of pulmonary edema
Time frame: Daily within first 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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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.
Mai Ibrahim Sobh, MBBS contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound measurement of caval aorta index in people with Fluid Balance, run by Mansoura University at 1 site in Egypt.
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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maha Ahmed Abozeid, Professor (02-01019216192, mahazed@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fluid balance (time frame: after 96 hours from the admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2026.