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Completed

NCT Number: NCT05195996

Beta Blocker Effects in Traumatic Brain Injury

The study will be conducted on polytrauma patient who are admitted from emergency room or postoperative with head trauma to evaluate effects of beta blocker on patients with TBI.

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Key information

Conditions

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

Age range

16 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine, University Hospitals

Shibīn al Kawm, Menoufia, 32511, Egypt

About this study

The study will be conducted on polytrauma patient who are admitted from emergency room or postoperative with head trauma . Patients will be randomly assigned into two groups by sealed envelope technique into two equal groups.

Parameters assessment:

  • Length of ICU stay
  • Length of total hospital stay
  • CT scan to exclude another intracranial hemorrhage or increase in hemorrhage
  • Functional status will be assessed using the GCS
  • Hemodynamic data ( bl.p / hr )
  • Crystalloid volume that patient need in 24h
  • Mortality rate

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • GCS preoperative >10
  • Abbreviated Injury Scale (AIS) >3
  • Length stay in ICU >48 h

Exclusion criteria

  • Hypersensitivity to propranolol
  • Asthmatic patient
  • COPD
  • History of smoking
  • Any cardiac problems eg: ( heart failure or HB )
  • pheochromocytoma
  • Pregnant patient
  • Length stay <48h
  • Death within 48 h of admission
  • Patient who previously received any beta blocker at home.
  • Symptomatic Bradycardia <60 b/m (sick sinus syndrome)
  • Hemodynamic unstable patients

Treatment and study plan

Propranolol

Drug

intravenous propranolol for case patients

Saline

Drug

intravenous saline for placebo

Primary outcomes

  1. survival

    Time frame: 7 days

    number of surviving in patients receiving propranolol and patients who did not receive any beta blocker

Secondary outcomes

  1. heart rate

    Time frame: 7 days

    number of patient showing effect of beta blocker on TBI related to HR

  2. icu stay

    Time frame: 7 days

    number of patients were beta blocker in TBI affected on ICU and total hospital stay

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

Beta Blocker Effects on Patients With Traumatic Brain Injury

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 19, 2022
Registry last updated
Mar 17, 2023

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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