Caval Aorta Index for Fluid Optimization in Traumatic Brain Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2026-07-31

Brief Summary

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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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Detailed Description

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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

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Fluid Balance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

A vascular US expert will read the number contained in computer generated randomization software and determine group assignments. Daily; he will be responsible on prescribing of the required fluid.

Study Groups

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Control group

Group Type OTHER

control group

Intervention Type OTHER

fixed fluid prescription

ultrasound-guided caval-aorta index group

Group Type EXPERIMENTAL

ultrasound measurement of caval aorta index

Intervention Type PROCEDURE

ultrasound measurement of caval aorta index

Interventions

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ultrasound measurement of caval aorta index

Intervention Type PROCEDURE

control group

fixed fluid prescription

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No