Using Propranolol in Traumatic Brain Injury to Reduce Sympathetic Storm Phenomenon

NCT ID: NCT03401515

Last Updated: 2018-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-01
• Study Completion Date: 2017-08-01

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 .

Detailed 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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention

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

Group Type: ACTIVE_COMPARATOR

Propranolol Hydrochloride 1 MG/ML

Intervention Type: DRUG

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

Control

Adminstration of normal saline 1 mg every 6 hrs

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: OTHER

Normal Saline 1 ml every 6 hrs

Interventions

Propranolol Hydrochloride 1 MG/ML

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

Intervention Type: DRUG

Normal saline

Normal Saline 1 ml every 6 hrs

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mona Ammar

Lecturer of anesthesia,intensive care and pain management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

1345 AUS

Identifier Type: -

Identifier Source: org_study_id