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NCT Number: NCT06870370

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propranolol

Drug

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

Normal saline IV

Drug

This group Will receive 1ml of sterile 0.9% normal saline IV every 6 hours for 7 days

Other names: control group

Primary outcomes

  1. Mortality

    Time frame: 7 days

    Mortality in severe traumatic brain injury with usage of β blocker

Secondary outcomes

  1. Glascow outcome scale extended

    Time frame: 7 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Huda Elkallaf, Resident

CONTACT

[email protected]

022 0 10 96213750

Huda Elkallaf, Resident

CONTACT

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 11, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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