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RECRUITING

NCT07899164

PHASE3

Efficacy of Propranolol in Traumatic Brain Injury Patients Admitted to the ICU: A Prospective, Randomized, Triple-Blind Study

Sponsor: Fundació d'investigació Sanitària de les Illes Balears

View on ClinicalTrials.gov

Summary

Beta-blockers have shown promise as a treatment to improve patient prognosis following traumatic brain injury (TBI), although the exact mechanism by which they might confer this benefit remains unknown. At the clinical level, several retrospective cohort studies, prospective cohort studies, small prospective clinical trials, and various reviews and meta-analyses suggest that beta-blockers may be associated with an improved prognosis in patients with TBI. Furthermore, the optimal timing, dosage, and duration of beta-blocker treatment remain uncertain. This means there is still uncertainty regarding the overall efficacy of beta-blockade in patients with TBI, as well as the specifics of patient selection, drugs, dosages, routes of administration, and physiological targets. In summary, the use of beta-blockers in patients with TBI appears to be associated with reduced mortality at the time of ICU discharge, as well as better long-term functional outcomes. However, the lack of high-quality scientific evidence clearly limits the ability to make a generalized recommendation regarding the use of beta-blockers in these patients. Therefore, further clinical trials are needed to analyze the effect of beta-blockers on mortality and short- and long-term functional outcomes in patients with TBI admitted to an Intensive Care Unit (ICU).

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

536

Start Date

2026-06-01

Completion Date

2028-12-01

Last Updated

2026-10-27

Healthy Volunteers

Conditions

Traumatic Brain Injury (TBI) Patients

Interventions

DRUG

Propranolol + Placebo

Patients with TBI admitted to these hospitals who meet the inclusion/exclusion criteria will be randomized to receive propranolol or placebo, administered orally or via nasogastric tube, for 14 days. The propranolol dosages used are those typically employed in the ICU: treatment begins with an initial dose of 10 mg every 6 hours (40 mg/day), which may be increased to a maximum of 40 mg every 4 hours (maximum 240 mg/day) based on blood pressure and heart rate parameters.

Inclusion Criteria: * Patients aged 18 to 80 years (inclusive) who have sustained a moderate or severe traumatic brain injury (GCS 3-13) and require ICU admission. * Signing of the informed consent by the patient or their legal representative, in the event that the patient is unable to do so. * Before starting the trial, the patient must be hemodynamically stable, defined as having a systolic blood pressure (SBP) of 110 mmHg or higher, a cerebral perfusion pressure (CPP) of 60 mmHg or higher (for patients with ICP monitoring), and a heart rate (HR) of 60 beats per minute or higher. Patients meeting these hemodynamic parameters while receiving a noradrenaline dose lower than 0.10 µg/kg/min may be included. * Initiation of the study within the first 96 hours following the trauma. Exclusion Criteria: * Age 17 years or younger, or 81 years or older (inclusive) * Hemodynamically unstable patients, defined as having a systolic blood pressure of 109 mmHg or less, a cerebral perfusion pressure of 59 mmHg or less (in patients with ICP monitoring), and a heart rate of 59 beats per minute or less, and requiring a noradrenaline dose greater than 0.10 µg/kg/min. * Lactic acid \>2 mmol/L at the time of randomization. * Patients with a TBI of more than 96 hours' duration * Polytrauma patients with an extracranial Injury Severity Score greater than 18 points or an extracranial AIS score of ≥4 in any region. * Patients with penetrating traumatic brain injury. * Pre-existing heart disease that contraindicates beta-blockers, such as first-, second-, or third-degree heart block without a permanent pacemaker; heart failure defined as an ejection fraction of less than 40%. * Patients receiving home treatment with digoxin, diltiazem, or verapamil. * Patients treated with beta-blockers prior to admission * Pre-existing asthma or bronchospasm * Patients with spinal cord injuries * Patients with both dilated pupils upon admission * Patients with a poor prognosis and a life expectancy inferior to 24 hours * Pregnant or breastfeeding women (a pregnancy test is required before inclusion in the clinical trial) * Patients with intolerance to any of the excipients contained in the propranolol or placebo capsules: lactose, calcium carboxymethylcellulose, gelatin (E441), magnesium stearate, hypromellose (E464), glycerol (E422), titanium dioxide (E171), carmine (E120), or sodium carboxymethylcellulose. * Patients for whom follow-up at one month and six months cannot be guaranteed. * Patients unable to take medication orally due to swallowing difficulties, and for whom the placement of a nasogastric tube is not indicated. * Patients enrolled in another clinical trial

Locations (6)

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, Spain

Hospital Germans Trias i Pujol

Badalona, Spain

Hospital Universitario de Burgos

Burgos, Spain

Hospital Universitario Arnau de Vilanova

Lleida, Spain

Hospital 12 de Octubre

Madrid, Spain

Hospital Universitario de Toledo

Toledo, Spain