Alcohol Withdrawal Syndrome Treated With Adjunctive Phenobarbital or Ketamine

Alcohol Withdrawal Syndrome Clinical Trial

— PKAT  

Official title:

A Randomized, Double-Blinded, Placebo-Controlled Study Evaluating Phenobarbital and Ketamine Adjunctive Therapies in the Treatment of Alcohol Withdrawal Syndrome

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03788889
• Other study ID #: 18-94
• Status: Withdrawn
• Phase: Phase 4
• Start date: April 12, 2019
• Est. completion date: April 12, 2019

Study information

• Verified date: September 2019
• Source: Santa Barbara Cottage Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 12, 2019
• Est. primary completion date: April 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Alcohol Withdrawal Syndrome
• Substance Withdrawal Syndrome
• Syndrome

Intervention

Drug:
• Ketamine
Ketamine infusion
• Phenobarbital
Phenobarbital intravenous injection
• Lorazepam
Standard of Care
• Placebo A
Placebo injection
• Placebo B
Placebo infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Santa Barbara Cottage Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensive Care Unit admission rate	Number of admissions to the intensive care unit	Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years
Secondary	Incidence of withdrawal seizures	Number of patients with documented seizures while treated for alcohol withdrawal syndrome	Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years
Secondary	Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) scores	CIWA-Ar scores (initial, maximum, discharge); Total score is cumulative of subscale measures: Minimum score is 0 (no evidence of alcohol withdrawal), Maximum score is 67 (severe alcohol withdrawal); Subscale measures: A) Nausea and vomiting (score 0-7); B) Tremor (score 0-7); C) Paroxysmal sweats (score 0-7); D) Anxiety (score 0-7); E) Tactile disturbances (score 0-7); F) Auditory disturbances (score 0-7); G) Visual disturbances (score 0-7); H) Headache, fullness in head (score 0-7); I) Agitation (score 0-7); J) Orientation and clouding of sensorium (score 0-4)	Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years
Secondary	Cumulative dose of medication/s administered	Cumulative dose of Lorazepam, Ketamine, and Phenobarbital	Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years
Secondary	Incidence of refractory alcohol withdrawal requiring alternative sedation with dexmedetomidine, propofol or midazolam infusions	Number of patients who require Dexmedetomidine, Propofol or Benzodiazepine continuous infusions and average dose while being treated for alcohol withdrawal syndrome	Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years
Secondary	Rate of mechanical ventilation	Rate of intubation	Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years
Secondary	Incidence of alcohol withdrawal hallucinations	Number of patients with documented auditory or visual hallucinations	Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years