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Not yet recruiting NCT06940258

Caval Aorta Index for Fluid Optimization in Traumatic Brain Injury

No phase Interventional Fluid Balance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ultrasound measurement of caval aorta index, control group.
Who it may be relevant to
Registry conditions: Fluid Balance. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Procedure ultrasound measurement of caval aorta index
    ultrasound measurement of caval aorta index
  • Other control group
    fixed fluid prescription

Primary outcome measures

  • fluid balance [Time frame: after 96 hours from the admission]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06940258 · Caval aorta index

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗