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Beta Blocker Effects in Traumatic Brain Injury

Primary Purpose

Trauma, Brain

Status

Completed

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Propranolol

Saline

About this trial

This is an interventional supportive care trial for Trauma, Brain

Eligibility Criteria

16 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

GCS preoperative >10
Abbreviated Injury Scale (AIS) >3
Length stay in ICU >48 h

Exclusion Criteria:

Hypersensitivity to propranolol
Asthmatic patient
COPD
History of smoking
Any cardiac problems eg: ( heart failure or HB )
pheochromocytoma
Pregnant patient
Length stay <48h
Death within 48 h of admission
Patient who previously received any beta blocker at home.
Symptomatic Bradycardia <60 b/m (sick sinus syndrome)
Hemodynamic unstable patients

Sites / Locations

Faculty of Medicine, University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

beta blocker

placebo

Arm Description

Will be given Propranolol 1mg in 10 ml distilled water intravenous every 6 hours for 48 hours

Will be given normal saline 10 ml every 6 hours for 48 hours

Outcomes

Primary Outcome Measures

survival

number of surviving in patients receiving propranolol and patients who did not receive any beta blocker

Secondary Outcome Measures

heart rate

number of patient showing effect of beta blocker on TBI related to HR

icu stay

number of patients were beta blocker in TBI affected on ICU and total hospital stay

Full Information

NCT ID

NCT05195996

First Posted

December 2, 2021

Last Updated

March 16, 2023

Sponsor

Menoufia University

1. Study Identification

Unique Protocol Identification Number

NCT05195996

Brief Title

Beta Blocker Effects in Traumatic Brain Injury

Official Title

Beta Blocker Effects on Patients With Traumatic Brain Injury

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

October 1, 2021 (Actual)

Primary Completion Date

March 31, 2022 (Actual)

Study Completion Date

May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Menoufia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

The study will be conducted on polytrauma patient who are admitted from emergency room or postoperative with head trauma to evaluate effects of beta blocker on patients with TBI.

Detailed Description

The study will be conducted on polytrauma patient who are admitted from emergency room or postoperative with head trauma . Patients will be randomly assigned into two groups by sealed envelope technique into two equal groups. Parameters assessment: Length of ICU stay Length of total hospital stay CT scan to exclude another intracranial hemorrhage or increase in hemorrhage Functional status will be assessed using the GCS Hemodynamic data ( bl.p / hr ) Crystalloid volume that patient need in 24h Mortality rate

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Trauma, Brain

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

beta blocker

Arm Type

Active Comparator

Arm Description

Will be given Propranolol 1mg in 10 ml distilled water intravenous every 6 hours for 48 hours

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

Will be given normal saline 10 ml every 6 hours for 48 hours

Intervention Type

Drug

Intervention Name(s)

Propranolol

Intervention Description

intravenous propranolol for case patients

Intervention Type

Drug

Intervention Name(s)

Saline

Intervention Description

intravenous saline for placebo

Primary Outcome Measure Information:

Title

survival

Description

number of surviving in patients receiving propranolol and patients who did not receive any beta blocker

Time Frame

7 days

Secondary Outcome Measure Information:

Title

heart rate

Description

number of patient showing effect of beta blocker on TBI related to HR

Time Frame

7 days

Title

icu stay

Description

number of patients were beta blocker in TBI affected on ICU and total hospital stay

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: GCS preoperative >10 Abbreviated Injury Scale (AIS) >3 Length stay in ICU >48 h Exclusion Criteria: Hypersensitivity to propranolol Asthmatic patient COPD History of smoking Any cardiac problems eg: ( heart failure or HB ) pheochromocytoma Pregnant patient Length stay <48h Death within 48 h of admission Patient who previously received any beta blocker at home. Symptomatic Bradycardia <60 b/m (sick sinus syndrome) Hemodynamic unstable patients

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

mostafa f mansour, MD

Organizational Affiliation

Menoufia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Medicine, University Hospitals

City

Shibīn Al Kawm

State/Province

Menoufia

ZIP/Postal Code

32511

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Beta Blocker Effects in Traumatic Brain Injury

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