Alcohol Withdrawal Syndrome Treated With Adjunctive Phenobarbital or Ketamine (PKAT)

Santa Barbara Cottage Hospital

Status and phase: Withdrawn; Phase 4

Conditions: Alcohol Withdrawal Syndrome

Treatments: Drug: Ketamine; Drug: Placebo A; Drug: Lorazepam; Drug: Placebo B; Drug: Phenobarbital

Study type: Interventional

Funder types: Other

Identifiers

NCT03788889

18-94

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

0 participants in 3 patient groups, including a placebo group

Lorazepam + Ketamine + Placebo A

Active Comparator group

Description:

Ketamine - infusion (0.15 - 0.4 mg/kg/hr) and placebo injections titrated by increases of 0.075 mg/kg/hr every 30 minutes for Clinical Institute Withdrawal Assessment for Alcohol (revised version) (CIWA-Ar) greater than or equal to 10 in addition to lorazepam symptom-triggered therapy Ketamine dosing will be based on ideal body weight Ketamine infusion will be discontinued once CIWA-Ar less than 10 for 4 hours

Treatment:

Drug: Lorazepam

Drug: Placebo A

Drug: Ketamine

Lorazepam + Phenobarbital + Placebo B

Active Comparator group

Description:

Phenobarbital - IV push (260 mg loading followed by 130 mg q1 hour) with placebo infusion until CIWA-Ar less than 10 with a maximum daily dose of 10mg/kg in addition to lorazepam symptom-triggered dosing for recurrent symptoms (Gold 2007) Maximum daily dose will be used in order to prevent over sedation as well as provide adequate storage in pharmacy monitored refrigerators for study drugs

Treatment:

Drug: Phenobarbital

Drug: Placebo B

Drug: Lorazepam

Lorazepam + Placebo A + Placebo B

Placebo Comparator group

Description:

Lorazepam will be administered every 30 minutes as indicated based on CIWA-Ar protocol for Cottage Health in addition to placebo injections and placebo infusion

Treatment:

Drug: Placebo B

Drug: Lorazepam

Drug: Placebo A