RecruitingPhase 4ACTRN12625000320459

Phenobarbital in combination benzodiazepine administration compared to benzodiazepine-only Treatment (usual care) for Alcohol Withdrawal Syndrome in the Intensive Care Unit

Phenobarbital as an Adjuvant to benzodiazepine administration when compared to Single-agent benzodiazepine Treatment (usual care) for Alcohol Withdrawal Syndrome in the Intensive Care Unit (PASTA): A single centre, three-arm, parallel group, electronic medical records embedded and randomised, feasibility trial


Sponsor

The Royal Melbourne Hospital

Enrollment

45 participants

Start Date

Aug 1, 2025

Study Type

Interventional

Conditions

Summary

The aim of this study is to determine whether it is feasible within an electronic medical record platform to screen, randomise, and direct the administration of intravenous phenobarbital, as an alternative to usual care, As well as the effect of phenobarbital administration in critically ill patients who are withdrawing from alcohol and are admitted to the Intensive Care Unit. We believe it is feasible to use an electronic medical record platform to guide this study intervention and that, based on current literature, phenobarbital is more effective than current usual care in the setting of alcohol withdrawal requiring ICU admission.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

Alcohol withdrawal can be a medical emergency, sometimes requiring admission to an intensive care unit (ICU). Standard treatment uses benzodiazepine medications, but these don't always work well enough for the most severe cases. This Phase 4 study is testing whether adding phenobarbital — an older but potentially more effective medication — to the standard treatment in the ICU can improve outcomes for critically ill patients withdrawing from alcohol. The study uses the hospital's electronic medical record system to identify eligible patients and guide the treatment. Participants will either receive phenobarbital plus standard care or standard care alone, with researchers tracking how quickly symptoms are controlled and whether any complications arise. This study is for adults aged 18 to 75 who have been admitted to the ICU and require treatment for alcohol withdrawal syndrome (defined by needing high doses of benzodiazepines). People with severe liver disease, certain drug interactions, allergies to phenobarbital, or who are pregnant are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

ARM 1. Intravenous infusion Phenobarbital low-dose (4 mg/kg ideal body weight) over 30 minutes + usual care. Thirty minutes after the initial phenobarbital administration, up to two additional intrave

ARM 1. Intravenous infusion Phenobarbital low-dose (4 mg/kg ideal body weight) over 30 minutes + usual care. Thirty minutes after the initial phenobarbital administration, up to two additional intravenous infusion of 2 mg/kg (ideal body weight) can be administered as required in a 48-hour period. Phenobarbital administration will be limited to a 48-hour period of administration. ARM 2. Intravenous infusion Phenobarbital standard-dose (8 mg/kg ideal body weight) over 30 minutes + usual care. Thirty minutes after the initial phenobarbital administration, up to two additional intravenous infusion of 2 mg/kg (ideal body weight) can be administered as required in a 48-hour period. Phenobarbital administration will be limited to a 48-hour period of administration. Adherence to the control will be monitored by confirmation of administration on the electronic medical records system (Epic EMR).


Locations(1)

VIC, Australia

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