Caval Aorta Index for Fluid Optimization in Traumatic Brain Injury (CAI for fluids)

April 25, 2025 updated by: maha abou-zeid, Mansoura University

Efficacy of Caval Aorta Index for Fluid Optimization in Critically Ill Patients With 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Maha Ahmed Abozeid, Assistant Professor
  • Phone Number: 02-01019216192
  • Email: mahazed@yahoo.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group
Other: control group
fixed fluid prescription
Experimental: ultrasound-guided caval-aorta index group
Procedure: ultrasound measurement of caval aorta index
ultrasound measurement of caval aorta index

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fluid balance
Time Frame: after 96 hours from the admission
the difference between fluid input and fluid loss
after 96 hours from the admission

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

April 15, 2025

First Submitted That Met QC Criteria

April 15, 2025

First Posted (Actual)

April 23, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2025

Last Update Submitted That Met QC Criteria

April 25, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Caval aorta index

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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