Role of Combined Therapy of Propranolol and Gabapentin in Paroxysmal Sympathetic Hyperactivity in Traumatic Brain Injury

NCT05427474 | Unknown Phase 3

• 1 other identifier: 9076-8-11-2021
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

Paroxysmal sympathetic hyperactivity (PSH) is a syndrome that comprises a series of signs and symptoms reflecting exacerbated sympathetic activity, including arterial hypertension, fever, tachycardia, generalized perspiration, anomalous motor activity (dystonia, muscle stiffness, extension), tachypnea, mechanical ventilator maladjustment, hypoxemia, hypercapnia, and hyperglycemia. PSH episodes can be intense and prolonged and can occur several times a day and all of these can lead to secondary brain damage and are the main causes of a poor prognosis. Paroxysmal sympathetic hyperactivity also induces a hypermetabolic state with hypercatabolism and inflammation and increases vulnerability to infections, sepsis, and weight loss which in turn are associated with increased morbidity, longer hospital stay, and slower recovery. The marked and sustained increase in catecholamine levels predisposes to the development of cardiomyopathy, lung edema, arrhythmias, and cardiac and multisystemic dysfunction. The reported incidence of paroxysmal sympathetic hyperactivity ranges from 8% to 33% and has no particular age or gender predilection. 80% of these syndrome incidents developed with traumatic brain injury.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• mortality rate of patients

  to record the mortality rate of each group of patients

  8 months

Secondary Outcomes (3)

• incidence of PSH

  8 months

• ICU length of stay

  8 months

• conscious level

  8 months

Study Arms (3)

standard protocol of manaegement

NO INTERVENTION

traumatic brain injury protocol in Emergency ICU without adding propranolol or gabapentin

propranolol group

ACTIVE COMPARATOR

addding propranolol to the traumatic brain injury protocol in Emergency ICU

Drug: Propranolol , gabapentin

combined propranolol and gabapentin

ACTIVE COMPARATOR

adding propranolol and gabapentin to the traumatic brain injury protocol in Emergency ICU

Drug: Propranolol , gabapentin

Interventions

Propranolol , gabapentin DRUG

The combined therapy of propranolol and gabapentine can prevent the occurrence of paroxysmal sympathetic hyperactivity in traumatic brain injury patients and improve the clinical outcomes in emergency ICU.

combined propranolol and gabapentin; propranolol group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ICU patients with moderate (GCS 9-12) to severe (GCS \<9) traumatic brain injury .

You may not qualify if:

• Pre-existing brain dysfunction .
• History of allergy to any of the combined drug therapy ( propranolol or gabapentine ) .
• History of obstructive lung disease .
• History of heart disease .
• Hypotension at admission of ICU.
• Bradycardia .
• Hypertension

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (2)

Zagazig University Hospitals

Zagazig, 055, Egypt

ACTIVE NOT RECRUITING

Zagazig University

Zagazig, 055, Egypt

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Propranolol; Gabapentin

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Essamedin Negm, MD

  Zagazig University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Essamedin Negm, MD

CONTACT

0201098123058; alpherdawss@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 22, 2022
• Study Start: December 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: October 31, 2023
• Last Updated: June 13, 2023

Record last verified: 2023-06

Locations

EG (2)