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NCT Number: NCT06940258

Caval Aorta Index for Fluid Optimization in 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.

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Key information

Conditions

Fluid Balance Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Traumatic brain injury diagnosed by computed tomography scan Glasgow coma score ≥ 4

Exclusion criteria

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

Treatment and study plan

ultrasound measurement of caval aorta index

Procedure

ultrasound measurement of caval aorta index

Control Group

Other

fixed fluid prescription

Primary outcomes

  1. fluid balance

    Time frame: after 96 hours from the admission

    the difference between fluid input and fluid loss

Secondary outcomes

  1. Urine output

    Time frame: Daily for 7 weeks

    mL

  2. Central Venous Pressure (CVP) measurements

    Time frame: Daily every 6 hours for 7 days

    cm H2O

  3. Frequency and duration of hypotension

    Time frame: within first 7 days

    systolic blood pressure less than 90 mmhg

  4. Glasgow Coma Scale

    Time frame: daily within first 7 days

    range from 3-to-15

  5. Central capillary refill

    Time frame: Daily for 7 days

    seconds

  6. incidence of pulmonary edema

    Time frame: Daily within first 7 days

    new B-lines in lung Ultrasound

Study contacts

Contact information is provided by the study sponsor or research team.

Maha Ahmed Abozeid, Assistant Professor

CONTACT

[email protected]

02-01019216192

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Efficacy of Caval Aorta Index for Fluid Optimization in Critically Ill Patients With Traumatic Brain Injury

Acronym: CAI for fluids

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 23, 2025
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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