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NCT Number: NCT06836856

Evaluating the Impact of Adjuvant Use of Beta Blockers on Clinical Outcomes in Patients With Traumatic Brain Injury

Propranolol primarily acts as a non-selective beta blocker, blocking both beta-1 and beta-2 adrenergic receptors, while carvedilol exhibits a broader spectrum of action by also blocking alpha-1 adrenergic receptors. The receptor blockade profile of a beta blocker can influence its physiological effects and potential therapeutic benefits in TBI. Therefore, the variation in receptor selectivity may result in differences in their impact on secondary brain injury processes and patient outcomes.

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Key information

Conditions

TBI Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Zagazig University Hospitals, Zagazig, Egypt

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with moderate & severe TBI detected on admission by CT scan and GCS score of ≤ 13 who either do not have any other injuries or only have associated minor injuries.

Minor injuries are defined as presence of any of the following:

  • Mild intraperitoneal free fluid (IPFF) observed through abdominal ultrasound.
  • mild lung contusion detected in the chest CT scan.
  • hemothorax or pneumothorax present without accompanying symptoms of hypoxia, tachypnea, or respiratory distress.
  • simple limb fractures.

Exclusion criteria

  • Patients on pre-injury beta-blocker therapy.
  • Patients with any bronchospastic conditions.
  • Patients with active acute coronary syndrome.
  • TBI with GCS ≤ 13 with associated major injuries defined as the presence of any of the following:
  • Moderate & marked IPFF requiring surgical intervention ( laparotomy ).
  • moderate & marked lung contusion, pneumothorax & hemothorax with accompanying symptoms of hypoxia, tachypnea, lower limbs, or limb amputation.
  • Compound fracture in the upper or lower limb.
  • Open Faciomaxillary trauma.
  • Patients with persistent shock (systemic blood pressure <100 mmHg, base deficit > 4, or oliguria , HR < 60 b/min ) after > one week of admission.

Treatment and study plan

Control

Drug

Patients will receive standard care with no interventions until end of treatment.

Propranolol

Drug

starting at 20mg propranolol three times daily by mouth or per feeding tube. The dose was increased daily in 20mg three times daily increments (60mg/day total) until heart rate (HR) was less than 100 beats per minute (bpm) with maximum dose of 640mg/day in addition to standard care until end of treatment.

Carvedilol

Drug

starting at 6.25mg carvedilol three times daily by mouth or per feeding tube. The dose was increased daily in 6.25 mg three times daily increments (18.75 mg/day total) until heart rate (HR) was less than 100 beats per minute (bpm) with maximum dose of 100 mg/day in addition to standard care until end of treatment.

Primary outcomes

  1. Incidence of In-hospital mortality

    Time frame: 14 days

    Difference between the study grous in terms of the percentage of all-cause mortality at the end of treatment

Study contacts

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

Aya Osama Nagaty

CONTACT

[email protected]

00201097721011

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2025
Registry last updated
Apr 2, 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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