Using Propranolol in Traumatic Brain Injury to Reduce Sympathetic Storm Phenomenon

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Traumatic Brain Injury

Treatments: Other: Normal saline; Drug: Propranolol Hydrochloride 1 MG/ML

Study type: Interventional

Funder types: Other

Identifiers

NCT03401515

1345 AUS

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Intervention

Active Comparator group

Description:

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

Treatment:

Drug: Propranolol Hydrochloride 1 MG/ML

Control

Placebo Comparator group

Description:

Adminstration of normal saline 1 mg every 6 hrs

Treatment:

Other: Normal saline