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Role of Non-Selective Beta-Adrenergic Blocker in Severe TBI

ConditionsTraumatic Brain Injury (TBI) PatientsIntracranial PressureIntensive Care UnitMortality
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTanta University

About this trial

The role of nonselective beta adrenergic blocker as antistress agent in severe traumatic brain injury

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged between 18and 65 years old

Patients who have Severe traumatic brain injury

Glascow outcome scale ≤ 8

Disqualifiers

Patients have pre-existing heart disease.

If there are contraindications to β blocker.

penetrating traumatic brain injury.

pre-injury brain dysfunction.

Trial design

Design model

Parallel

Treatments tested in this trial

  • propranolol

    Drug

    This group Will receive propranolol intravenously at a dose of 1 mg every 6 h for 7 days, and doses will be held if heart rate less than 60 bpm, mean arterial pressure less than 65 mmHg

  • normal saline IV

    Drug

    This group Will receive 1ml of sterile 0.9% normal saline IV every 6 hours for 7 days

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Propranolol groupExperimental treatment 1 intervention
Group B: normal saline IV groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mortality

Mortality in severe traumatic brain injury with usage of β blocker

Time frame
7 days

Secondary outcomes

1

Glascow outcome scale extended

Glascow outcome scale extended) consists of 8 categories: Death Persistent vegetative state: awake not aware. Lower severe disability: dependent, require help most of time. Upper severe disability: dependent, can be left alone some time. Iower moderate disability: independent, unable to work. Upper moderate disability: independent, reduced work capacity. Lower good recovery: minor problems that affect daily activities. Upper good recovery: no current problems related to brain injury.

Time frame
7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: