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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
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

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

    First Posted
    November 21, 2017
    Last Updated
    January 16, 2018
    Sponsor
    Ain Shams University
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    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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