Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Using Propranolol in Traumatic Brain Injury to Reduce Sympathetic Storm Phenomenon

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03401515
Recruitment Status : Completed
First Posted : January 17, 2018
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Mona Ammar, Ain Shams University

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 .

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Drug: Propranolol Hydrochloride 1 MG/ML Other: Normal saline Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : June 10, 2017
Actual Study Completion Date : August 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intervention
Adminstration of propranolol hydrochloride ( 1 MG /ml) 1 mg every 6 hrs .
Drug: Propranolol Hydrochloride 1 MG/ML
Propranolol 1 mg every 6 hrs in the first 24 hrs after isolated blunt traumatic brain injury

Placebo Comparator: Control
Adminstration of normal saline 1 mg every 6 hrs
Other: Normal saline
Normal Saline 1 ml every 6 hrs




Primary Outcome Measures :
  1. catecholamine level [ Time Frame: 7 days ]
    Norepinephrine plasma levels in pg./ml


Secondary Outcome Measures :
  1. Temperature [ Time Frame: 7 days ]
    Temperature in °C



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Layout table for additonal information
Responsible Party: Mona Ammar, Lecturer of anesthesia,intensive care and pain management, Ain Shams University
ClinicalTrials.gov Identifier: NCT03401515     History of Changes
Other Study ID Numbers: 1345 AUS
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents