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Completed

NCT Number: NCT03401515

Using Propranolol in Traumatic Brain Injury to Reduce Sympathetic Storm Phenomenon

Traumatic Brain Injury (TBI) is one of the leading causes of death. Severe TBT is correlated with an exaggerated stress response due to plasma catecholamine levels known as sympathetic storming. It is also autonomic dysfunction syndrome. This phenomenon is also associated with brain tumors, severe hydrocephalus and subarachnoid hemorrhage. Patients are presented by tachycardia, tachypnea hypertension, diaphoresis, dystonia, hyperthermia, and dilated pupils with elevated levels of plasma catecholamine and blood glucose .

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Key information

About this study

The sympathetic storming events can be triggered by suctioning, repositioning, or environmental stimuli. To differentiate sympathetic storming from similar conditions, symptoms and signs have to occur in TBI patients a minimum of 1 cycle per day for 3 consecutive days (body temperature of 38.5 °C or more, heart rate at least 120 beat / min, systolic blood pressure > 140 mmHg, respiratory rate > 20 breaths / min, in presence of dystonia, diaphoresis, agitation and laboratory investigations confirm elevated serum catecholamines. Beta blockers has a cardio protective effect via lowering heart rate, stroke volume and mean arterial blood pressure which limits myocardial O2 consumptions and guards against myocardial infarction. They also have neuron protective effects via reducing cerebral blood flow thus lowering O2 and glucose consumption as cerebral metabolism is reduced. Propranolol a nonselective B receptor antagonists works on β1 receptors in brain, heart, and kidney and β 2 receptors in lungs, liver, skeletal muscles, eye and arterioles.We suppose that using Beta - adrenergic receptor blockers as propranolol blunts the sympathetic storming phenomenon as it is a nonselective β inhibitor and has a lipophilic property which enables it to penetrate blood brain barrier.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with isolated blunt TBI
  • From 18 to 60 years old both sex
  • Not in need of mechanical ventilation
  • GCS on admission between 9 and 12
  • Rotterdam CT score from 2-4.
  • Normal Procalcitonin test to exclude infection.

Exclusion criteria

  • Preexisting heart disease
  • Myocardial injury
  • Craniotomy
  • Preexisting cerebral dysfunction
  • Spinal cord injury
  • Diabetes mellitus
  • Severe liver or kidney disease
  • Patients with sepsis

Treatment and study plan

Propranolol Hydrochloride 1 MG/ML

Drug

Propranolol 1 mg every 6 hrs in the first 24 hrs after isolated blunt traumatic brain injury

Normal Saline

Other

Normal Saline 1 ml every 6 hrs

Primary outcomes

  1. catecholamine level

    Time frame: 7 days

    Norepinephrine plasma levels in pg./ml

Secondary outcomes

  1. Temperature

    Time frame: 7 days

    Temperature in °C

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Using Propranolol in Traumatic Brain Injury to Reduce Sympathetic Storm Phenomenon: A Prospective Randomized Clinical Trial Injury to Reduce Sympathetic Storm Phenomenon: A Prospective Randomized Clinical Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 17, 2018
Registry last updated
Jan 17, 2018

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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