Alcohol Withdrawal Syndrome Treated With Adjunctive Phenobarbital or Ketamine
NCT ID: NCT03788889
Last Updated: 2019-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2019-04-12
2019-04-12
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Each medication will be packaged by Santa Barbara Cottage Hospital pharmacy. In order to blind both the clinicians and the participants, the pharmacy will provide medication bags that are identical. Therefore, Emergency Department nursing staff and physicians will be unaware of which study drug is being provided to the patient. Normal saline will be used as a placebo to mimic study drugs (phenobarbital and ketamine). Pharmacy will remain unblinded and maintain records of which treatment assignment is prepared for each patient.
Treatment will be provided for the duration of the patient's hospitalization; therefore, treatment compliance will be documented in the electronic health record using the medication bag identifier.
Study Groups
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Lorazepam + Ketamine + Placebo A
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
Ketamine
Ketamine infusion
Lorazepam
Standard of Care
Placebo A
Placebo injection
Lorazepam + Phenobarbital + Placebo B
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
Phenobarbital
Phenobarbital intravenous injection
Lorazepam
Standard of Care
Placebo B
Placebo infusion
Lorazepam + Placebo A + Placebo B
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
Lorazepam
Standard of Care
Placebo A
Placebo injection
Placebo B
Placebo infusion
Interventions
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Ketamine
Ketamine infusion
Phenobarbital
Phenobarbital intravenous injection
Lorazepam
Standard of Care
Placebo A
Placebo injection
Placebo B
Placebo infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnancy;
* Inability to obtain intravenous access;
* Child Pugh Class C; and
* Allergy to study medications (phenobarbital, ketamine, lorazepam).
18 Years
ALL
No
Sponsors
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Santa Barbara Cottage Hospital
OTHER
Responsible Party
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Principal Investigators
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Noah Stites-Hallet, MD
Role: PRINCIPAL_INVESTIGATOR
Santa Barbara Cottage Hospital
Other Identifiers
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18-94
Identifier Type: -
Identifier Source: org_study_id
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