Using Propranolol in Traumatic Brain Injury to Reduce Sympathetic Storm Phenomenon
Primary Purpose
Traumatic Brain Injury
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Propranolol Hydrochloride 1 MG/ML
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intervention
Control
Arm Description
Adminstration of propranolol hydrochloride ( 1 MG /ml) 1 mg every 6 hrs .
Adminstration of normal saline 1 mg every 6 hrs
Outcomes
Primary Outcome Measures
catecholamine level
Norepinephrine plasma levels in pg./ml
Secondary Outcome Measures
Temperature
Temperature in °C
Full Information
NCT ID
NCT03401515
First Posted
November 21, 2017
Last Updated
January 16, 2018
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT03401515
Brief Title
Using Propranolol in Traumatic Brain Injury to Reduce Sympathetic Storm Phenomenon
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
June 10, 2017 (Actual)
Study Completion Date
August 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Adminstration of propranolol hydrochloride ( 1 MG /ml) 1 mg every 6 hrs .
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Adminstration of normal saline 1 mg every 6 hrs
Intervention Type
Drug
Intervention Name(s)
Propranolol Hydrochloride 1 MG/ML
Intervention Description
Propranolol 1 mg every 6 hrs in the first 24 hrs after isolated blunt traumatic brain injury
Intervention Type
Other
Intervention Name(s)
Normal saline
Intervention Description
Normal Saline 1 ml every 6 hrs
Primary Outcome Measure Information:
Title
catecholamine level
Description
Norepinephrine plasma levels in pg./ml
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Temperature
Description
Temperature in °C
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
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Using Propranolol in Traumatic Brain Injury to Reduce Sympathetic Storm Phenomenon
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