Evaluating the Impact of Adjuvant Use of Beta Blockers on Clinical Outcomes in Patients With Traumatic Brain Injury

NCT ID: NCT06836856

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-20
• Study Completion Date: 2025-06-30

Brief Summary

Propranolol primarily acts as a non-selective beta blocker, blocking both beta-1 and beta-2 adrenergic receptors, while carvedilol exhibits a broader spectrum of action by also blocking alpha-1 adrenergic receptors. The receptor blockade profile of a beta blocker can influence its physiological effects and potential therapeutic benefits in TBI. Therefore, the variation in receptor selectivity may result in differences in their impact on secondary brain injury processes and patient outcomes.

Conditions

TBI Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Arm

Group Type: PLACEBO_COMPARATOR

control

Intervention Type: DRUG

Patients will receive standard care with no interventions until end of treatment.

propranolol

propranolol

Group Type: ACTIVE_COMPARATOR

propranolol

Intervention Type: DRUG

starting at 20mg propranolol three times daily by mouth or per feeding tube. The dose was increased daily in 20mg three times daily increments (60mg/day total) until heart rate (HR) was less than 100 beats per minute (bpm) with maximum dose of 640mg/day in addition to standard care until end of treatment.

carvedilol

Carvid (carvedilol)

Group Type: ACTIVE_COMPARATOR

Carvedilol

Intervention Type: DRUG

starting at 6.25mg carvedilol three times daily by mouth or per feeding tube. The dose was increased daily in 6.25 mg three times daily increments (18.75 mg/day total) until heart rate (HR) was less than 100 beats per minute (bpm) with maximum dose of 100 mg/day in addition to standard care until end of treatment.

Interventions

control

Patients will receive standard care with no interventions until end of treatment.

Intervention Type: DRUG

propranolol

starting at 20mg propranolol three times daily by mouth or per feeding tube. The dose was increased daily in 20mg three times daily increments (60mg/day total) until heart rate (HR) was less than 100 beats per minute (bpm) with maximum dose of 640mg/day in addition to standard care until end of treatment.

Intervention Type: DRUG

Carvedilol

starting at 6.25mg carvedilol three times daily by mouth or per feeding tube. The dose was increased daily in 6.25 mg three times daily increments (18.75 mg/day total) until heart rate (HR) was less than 100 beats per minute (bpm) with maximum dose of 100 mg/day in addition to standard care until end of treatment.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients with moderate & severe TBI detected on admission by CT scan and GCS score of ≤ 13 who either do not have any other injuries or only have associated minor injuries.

Minor injuries are defined as presence of any of the following:

1. Mild intraperitoneal free fluid (IPFF) observed through abdominal ultrasound.

2. mild lung contusion detected in the chest CT scan.

3. hemothorax or pneumothorax present without accompanying symptoms of hypoxia, tachypnea, or respiratory distress.

4. simple limb fractures.

Exclusion Criteria

1. Patients on pre-injury beta-blocker therapy.

2. Patients with any bronchospastic conditions.

3. Patients with active acute coronary syndrome.

4. TBI with GCS ≤ 13 with associated major injuries defined as the presence of any of the following:

1. Moderate & marked IPFF requiring surgical intervention ( laparotomy ).

2. moderate & marked lung contusion, pneumothorax & hemothorax with accompanying symptoms of hypoxia, tachypnea, lower limbs, or limb amputation.

3. Compound fracture in the upper or lower limb.

4. Open Faciomaxillary trauma.

5. Patients with persistent shock (systemic blood pressure <100 mmHg, base deficit > 4, or oliguria , HR < 60 b/min ) after > one week of admission.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Noha Mansour

Associate Profesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zagazig University Hospitals, Zagazig,

Zagazig, , Egypt

Site Status: RECRUITING

Zagazig University Hospitals

Zagazig, , Egypt

Site Status: NOT_YET_RECRUITING

Countries

Egypt

Central Contacts

Aya Osama Nagaty

Role: CONTACT

doctoraya_15@yahoo.com

00201097721011

Other Identifiers

2024-37

Identifier Type: -

Identifier Source: org_study_id