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Clinical Trials/NCT06940258
NCT06940258Not yet recruitingNot Applicable

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

Mansoura University0 sites92 target enrollmentStarted: May 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
92
Primary Endpoint
fluid balance

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Masking Description

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.

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Control group

Other

Intervention: control group (Other)

ultrasound-guided caval-aorta index group

Experimental

Intervention: ultrasound measurement of caval aorta index (Procedure)

Outcomes

Primary Outcomes

fluid balance

Time Frame: after 96 hours from the admission

the difference between fluid input and fluid loss

Secondary Outcomes

  • Central capillary refill(Daily for 7 days)
  • Central Venous Pressure (CVP) measurements(Daily every 6 hours for 7 days)
  • Frequency and duration of hypotension(within first 7 days)
  • Glasgow Coma Scale(daily within first 7 days)
  • incidence of pulmonary edema(Daily within first 7 days)
  • Urine output(Daily for 7 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

maha abou-zeid

Assistant Professor of Anesthesia and Surgical Intensive Care

Mansoura University

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