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Alcohol Withdrawal SyndromePhase 4PKATNCT03788889

Alcohol Withdrawal Syndrome Treated With Adjunctive Phenobarbital or Ketamine

A Phase 4 study testing Ketamine, Phenobarbital and Lorazepam in people with Alcohol Withdrawal Syndrome, run by Santa Barbara Cottage Hospital.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alcohol Withdrawal Syndrome
What is being tested?
Ketamine, Phenobarbital and Lorazepam
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
12 Apr 2019to 12 Apr 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

About this study

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

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.

Read the 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.

Being tested
Ketamine, Phenobarbital, Lorazepam, Placebo A, Placebo B
Keywords
Lorazepam, Ketamine, Phenobarbital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KetamineDrug

    Also called Ketalar

    Ketamine infusion

  • PhenobarbitalDrug

    Also called Solfoton, Luminal

    Phenobarbital intravenous injection

  • LorazepamDrug

    Also called Ativan

    Standard of Care

  • Placebo ADrug

    Also called Normal saline

    Placebo injection

  • Placebo BDrug

    Also called Normal saline

    Placebo infusion

Study groups in NCT03788889
Study groupRoleWhat they receive
Lorazepam + Ketamine + Placebo AActive comparatorKetamine - 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
Receives: Drug: Ketamine; Drug: Lorazepam; Drug: Placebo A
Lorazepam + Phenobarbital + Placebo BActive comparatorPhenobarbital - 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
Receives: Drug: Phenobarbital; Drug: Lorazepam; Drug: Placebo B
Lorazepam + Placebo A + Placebo BPlacebo comparatorLorazepam will be administered every 30 minutes as indicated based on CIWA-Ar protocol for Cottage Health in addition to placebo injections and placebo infusion
Receives: Drug: Lorazepam; Drug: Placebo A; Drug: Placebo B

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intensive Care Unit admission rate

    Number of admissions to the intensive care unit

    Measured: Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years

Secondary outcomes (6)

  1. Incidence of withdrawal seizures

    Number of patients with documented seizures while treated for alcohol withdrawal syndrome

    Measured: Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years

  2. 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:

    1. 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)

    Measured: Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years

  3. Cumulative dose of medication/s administered

    Cumulative dose of Lorazepam, Ketamine, and Phenobarbital

    Measured: Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years

  4. 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

    Measured: Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years

  5. Rate of mechanical ventilation

    Rate of intubation

    Measured: Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years

  6. Incidence of alcohol withdrawal hallucinations

    Number of patients with documented auditory or visual hallucinations

    Measured: Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2018
  2. Study start12 Apr 2019 (estimated)
  3. Primary completion12 Apr 2019
  4. Study completion12 Apr 2019

Why it stopped: internal practice and policy limitations including time commitment / workflow issues

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
prospective, randomized control trial
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03788889
Sponsor's protocol ID
18-94
Acronym
PKAT
Status last verified
Sep 2019
First submitted
22 Dec 2018
Last updated
19 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ketamine, Phenobarbital and Lorazepam in people with Alcohol Withdrawal Syndrome, run by Santa Barbara Cottage Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intensive Care Unit admission rate (time frame: Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03788889.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.

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