Caval Aorta Index for Fluid Optimization in Traumatic Brain Injury

NCT06940258 | Not Yet Recruiting

• 1 other identifier: Caval aorta index
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fluid Balance

Keywords

caval aorta index; traumatic brain injury

Outcome Measures

Primary Outcomes (1)

• fluid balance

  the difference between fluid input and fluid loss

  after 96 hours from the admission

Secondary Outcomes (6)

• Urine output

  Daily for 7 weeks

• 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

• Central capillary refill

  Daily for 7 days

Study Arms (2)

Control group

OTHER

Other: control group

ultrasound-guided caval-aorta index group

EXPERIMENTAL

Procedure: ultrasound measurement of caval aorta index

Interventions

ultrasound measurement of caval aorta index PROCEDURE

ultrasound measurement of caval aorta index

ultrasound-guided caval-aorta index group

control group OTHER

fixed fluid prescription

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Traumatic brain injury diagnosed by computed tomography scan Glasgow coma score ≥ 4

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Maha Ahmed Abozeid, Assistant Professor

CONTACT

02-01019216192; mahazed@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia and Surgical Intensive Care

Model Details: 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)

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 23, 2025
• Study Start: May 1, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 29, 2025

Record last verified: 2025-04