Role of Non-Selective Beta-Adrenergic Blocker in Severe TBI

Role of Non-Selective Beta-Adrenergic Blocker in Severe Traumatic Brain Injury

The role of nonselective beta adrenergic blocker as antistress agent in severe traumatic brain injury

Study Overview

• Status: Not yet recruiting
• Conditions: Mortality; Intensive Care Unit; Intracranial Pressure; Traumatic Brain Injury (TBI) Patients
• Intervention / Treatment: Drug: propranolol; Drug: normal saline IV

Detailed Description

The primary injury occurs at the time of trauma. secondary injury is caused by complications of the primary insult and caused by processes such as hypoxia, cerebral edema and ischemia.

Severe traumatic brain injury is associated with increased intracranial pressure, activation of the sympathetic nervous system and catecholamine response and major morbidity and mortality .

β-blockade is just one pharmacologic strategy to reduce sympathetic hyperactivity. In the Intensive care unit patients with severe traumatic brain injury associated with restlessness and agitation are frequently sedated and intubated in order to reduce the workload of the brain. This hyperactive response is called sympathetic storming which occurs within 24 hours of brain injury or weeks later . It occurs due to acceleration in sympathetic nervous system activity in the central nervous system which results in loss of cortical control due to downregulation of autonomic balance in the brain injury .

A Non-Selective beta-adrenergic antagonist propranolol, is one of the most customarily used treatments in the case of paroxysmal sympathetic hyperactivity.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Huda Elkallaf, Resident; Phone Number: 022 0 10 96213750; Email: hoda171661_pg@med.tanta.edu.eg
• Study Contact Backup: Name: Huda Elkallaf, Resident

Study Locations

• Egypt
  • Tanta, Egypt, 31527
    • Tanta University
    • Contact: Huda Elkallaf, Resident; Phone Number: +20 10 96213750; Email: hoda171661_pg@med.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged between 18and 65 years old
• Patients who have Severe traumatic brain injury
• Glascow outcome scale ≤ 8

Exclusion Criteria:

• Patients have pre-existing heart disease.
• If there are contraindications to β blocker.
• penetrating traumatic brain injury.
• pre-injury brain dysfunction.
• β-blocker or α2-agonist use before trauma.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Propranolol group; This group Will receive propranolol intravenously at a dose of 1 mg every 6 h for 7 days.	Drug: propranolol; This group Will receive propranolol intravenously at a dose of 1 mg every 6 h for 7 days, and doses will be held if heart rate less than 60 bpm, mean arterial pressure less than 65 mmHg; Other Names: Experimental group
Placebo Comparator: normal saline IV group; This group Will receive 1ml of sterile 0.9% normal saline IV every 6 hours for 7 days	Drug: normal saline IV; This group Will receive 1ml of sterile 0.9% normal saline IV every 6 hours for 7 days; Other Names: control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality in severe traumatic brain injury with usage of β blocker	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glascow outcome scale extended	Glascow outcome scale extended) consists of 8 categories: Death Persistent vegetative state: awake not aware. Lower severe disability: dependent, require help most of time. Upper severe disability: dependent, can be left alone some time. Iower moderate disability: independent, unable to work. Upper moderate disability: independent, reduced work capacity. Lower good recovery: minor problems that affect daily activities. Upper good recovery: no current problems related to brain injury.	7 days

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Huda Elkallaf, Resident, Tanta University

Study record dates

Study Major Dates

• Study Start (Estimated): September 20, 2025
• Primary Completion (Estimated): September 20, 2025
• Study Completion (Estimated): September 20, 2025

Study Registration Dates

• First Submitted: March 6, 2025
• First Submitted That Met QC Criteria: March 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries, Traumatic; Brain Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Anti-Arrhythmia Agents; Adrenergic Agents; Vasodilator Agents; Antihypertensive Agents; Adrenergic beta-Antagonists; Adrenergic Antagonists; Propranolol
• Other Study ID Numbers: 36264MS291/8/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon reasonable request from principle investigator
• IPD Sharing Time Frame: For one year
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No