Clinical trial NCT03788889: Alcohol Withdrawal Syndrome Treated With Adjunctive Phenobarbital or Ketamine
Official title: A Randomized, Double-Blinded, Placebo-Controlled Study Evaluating Phenobarbital and Ketamine Adjunctive Therapies in the Treatment of Alcohol Withdrawal Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Alcohol Withdrawal Syndrome
Keywords: Lorazepam
Ketamine
Phenobarbital
Lead sponsor: Santa Barbara Cottage Hospital
Sponsor class: OTHER
First posted: 2018-12-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized control trial
Primary purpose: TREATMENT

Brief summary: The goal of this study will aim to determine if adding phenobarbital or ketamine to a symptom-triggered benzodiazepine regimen decreases the rate of intensive care unit admissions during the treatment of alcohol withdrawal syndrome when compared to symptom-triggered benzodiazepine therapy alone.

Detailed description: The primary objective of this study is to compare phenobarbital and ketamine adjunctive therapies to lorazepam-based therapy in the treatment of acute alcohol withdrawal syndrome.

It is hypothesized that the use of an alternative agent, either phenobarbital or ketamine, when used as an adjunct to symptom-triggered lorazepam therapy will significantly reduce the rate of intensive care unit admissions and thereby reduce the total cost associated with hospital admission for treatment of alcohol withdrawal syndrome.

Enrolled patients will be admitted to Santa Barbara Cottage Hospital where they will be monitored with continuous pulse oximetry and cardiac telemetry. They will remain hospitalized while undergoing study-guided therapy in addition to supportive care for acute alcohol withdrawal syndrome. Patients will undergo standard of care therapy with lorazepam symptom-triggered therapy regardless of study participation.

Eligibility criteria: Inclusion Criteria:

* Primary admitting diagnosis of acute alcohol withdrawal syndrome based on International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10), code F10.3, F10.4.

Exclusion Criteria:

* Significant comorbid medical illness requiring Intensive Care Unit admission;
* Pregnancy;
* Inability to obtain intravenous access;
* Child Pugh Class C; and
* Allergy to study medications (phenobarbital, ketamine, lorazepam).

Primary outcomes:
measure: Intensive Care Unit admission rate
timeFrame: Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years
Secondary outcomes:
measure: Incidence of withdrawal seizures
timeFrame: Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years
measure: Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) scores
timeFrame: Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years
measure: Cumulative dose of medication/s administered
timeFrame: Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years
measure: Incidence of refractory alcohol withdrawal requiring alternative sedation with dexmedetomidine, propofol or midazolam infusions
timeFrame: Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years
measure: Rate of mechanical ventilation
timeFrame: Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years
measure: Incidence of alcohol withdrawal hallucinations
timeFrame: Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Santa Barbara Cottage Hospital
name: Noah Stites-Hallet, MD
role: PRINCIPAL_INVESTIGATOR
References: