Using Propranolol in Traumatic Brain Injury to Reduce Sympathetic Storm Phenomenon

Traumatic Brain Injury Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03401515
• Other study ID #: 1345 AUS
• Status: Completed
• Phase: Phase 4
• First received: November 21, 2017
• Last updated: January 16, 2018
• Start date: October 1, 2016
• Est. completion date: August 1, 2017

Study information

• Verified date: January 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 .

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 1, 2017
• Est. primary completion date: June 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Drug:
• Propranolol Hydrochloride 1 MG/ML
Propranolol 1 mg every 6 hrs in the first 24 hrs after isolated blunt traumatic brain injury

Other:
• Normal saline
Normal Saline 1 ml every 6 hrs

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	catecholamine level	Norepinephrine plasma levels in pg./ml	7 days
Secondary	Temperature	Temperature in °C	7 days