Using Propranolol in Traumatic Brain Injury to Reduce Sympathetic Storm Phenomenon

NCT03401515 | Completed Phase 4

• 1 other identifier: 1345 AUS
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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 .

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• catecholamine level

  Norepinephrine plasma levels in pg./ml

  7 days

Secondary Outcomes (1)

• Temperature

  7 days

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Adminstration of propranolol hydrochloride ( 1 MG /ml) 1 mg every 6 hrs .

Drug: Propranolol Hydrochloride 1 MG/ML

Control

PLACEBO COMPARATOR

Adminstration of normal saline 1 mg every 6 hrs

Other: Normal saline

Interventions

Propranolol Hydrochloride 1 MG/ML DRUG

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

Intervention

Normal saline OTHER

Normal Saline 1 ml every 6 hrs

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Propranolol; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia,intensive care and pain management

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: January 17, 2018
• Study Start: October 1, 2016
• Primary Completion: June 10, 2017
• Study Completion: August 1, 2017
• Last Updated: January 17, 2018

Record last verified: 2018-01