Caval Aorta Index for Fluid Optimization in Traumatic Brain Injury

Not Applicable

Not yet recruiting

• Conditions: Fluid Balance

• Registration Number: NCT06940258
• Lead Sponsor: Mansoura University

Brief 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 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 Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-15
• Study First Submitted QC: 2025-04-15
• Study First Posted: 2025-04-23
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-29
• Study Start: 2025-05-01
• Primary Completion: 2026-04-30
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
fluid balance	after 96 hours from the admission	the difference between fluid input and fluid loss

Secondary Outcome Measures

Name	Time	Method
Central Venous Pressure (CVP) measurements	Daily every 6 hours for 7 days	cm H2O
Frequency and duration of hypotension	within first 7 days	systolic blood pressure less than 90 mmhg
Glasgow Coma Scale	daily within first 7 days	range from 3-to-15
Central capillary refill	Daily for 7 days	seconds
incidence of pulmonary edema	Daily within first 7 days	new B-lines in lung Ultrasound
Urine output	Daily for 7 weeks	mL