Alcohol Withdrawal SyndromeNCT01652326
Clinical Quality Improvement of Benzodiazepine-Resistant Alcohol Withdrawal Syndrome
An observational study of Alcohol Withdrawal Syndrome, run by University of Pittsburgh at 1 site in United States.
Trial summary
The overarching goal of this project is to improve the clinical quality of patients with Benzodiazepine-resistant alcohol withdrawal syndrome. 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?
- Diazepam
- Type of treatment
- Injection or infusion
- How many people
- 792 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Sep 2015
- Phase
- Observational
- 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
Study population: hospitalized inpatients
Who may be able to join
- either
- a requirement of either 200 mg of diazepam (or diazepam equivalents) in 4 hrs;
- > 40mg of diazepam (or diazepam equivalents) in 1 hr; or
- an individual dose of 40 mg or greater of intravenous diazepam for control of agitation
Who cannot join
- if < 18 years of age or had evidence of use of other illicit substances as determined by urine toxicology screen
Trial locations and contacts
1 site in 1 country.
About this study
The overarching goal of this project is to improve the clinical quality of patients with Benzodiazepine-resistant alcohol withdrawal syndrome.
- Conditions
- Alcohol Withdrawal Syndrome
- Being tested
- Diazepam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiazepamDrug
| Study group | Role | What they receive |
|---|---|---|
| Benzodiazepine-resistant | those patients with either 1) a requirement of either 200 mg of diazepam (or diazepam equivalents) in 4 hrs; 2) >40mg of diazepam (or diazepam equivalents) in 1 hr; or 3) an individual dose of 40 mg or greater of intravenous diazepam for control of agitation Receives: Drug: Diazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify those risk factors predictive of benzodiazepine-resistant alcohol withdrawal syndrome
Measured: up to 38 months
Secondary outcomes (3)
Drug utilization of phenobarbital, propofol, dexmedetomidine, and ketamine in benzodiazepine-resistant alcohol withdrawal syndrome
Will compare the frequency, duration and dosages of the above agents when used for benzodiazepine-resistant alcohol withdrawal
Measured: Up to 38 months
Effectiveness of phenobarbital, propofol, dexmedetomidine, and ketamine in benzodiazepine-resistant alcohol withdrawal
Comparative markers will include:
- Presence or absence of the following: delirium tremens, hallucinosis, seizures, or arrhythmias
- Indication and duration of mechanical intubation
- Nosocomial infection rates
- ICU length of stay
Measured: Up to 38 months
Tolerability of phenobarbital, propofol, dexmedetomidine, and ketamine in benzodiazepine-resistant alcohol withdrawal
Comparative markers will include:
- Rikers Sedation Scale Assessments
- Hypotension
- Hypertriglyceridemia/Pancreatitis
- Drug induced hallucinosis or seizures
Measured: Up to 38 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Withdrawal SyndromeStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 792 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Hospira, now a wholly owned subsidiary of Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652326
- Sponsor's protocol ID
- UPittsburgh 0031860
- Status last verified
- Jan 2016
- First submitted
- 20 Jul 2012
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Quality Improvement of Benzodiazepine-Resistant Alcohol Withdrawal Syndrome
- ClinicalTrials.gov ID
- NCT01652326
- Acronym / sponsor ID
- UPittsburgh 0031860
- Conditions
- Alcohol Withdrawal Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 792 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Hospira, now a wholly owned subsidiary of Pfizer
- Study start
- Jul 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 30 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overarching goal of this project is to improve the clinical quality of patients with Benzodiazepine-resistant alcohol withdrawal syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Benzodiazepine-resistant | – | Drug: Diazepamthose patients with either 1) a requirement of either 200 mg of diazepam (or diazepam equivalents) in 4 hrs; 2) >40mg of diazepam (or diazepam equivalents) in 1 hr; or 3) an individual dose of 40 mg or greater of intravenous diazepam for control of agitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hospitalized inpatients
Key inclusion criteria (4 listed)
- either
- a requirement of either 200 mg of diazepam (or diazepam equivalents) in 4 hrs;
- > 40mg of diazepam (or diazepam equivalents) in 1 hr; or
- an individual dose of 40 mg or greater of intravenous diazepam for control of agitation
Key exclusion criteria (1 listed)
- if < 18 years of age or had evidence of use of other illicit substances as determined by urine toxicology screen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diazepam | Drug | Benzodiazepine-resistant |
Primary outcome
Identify those risk factors predictive of benzodiazepine-resistant alcohol withdrawal syndrome
Time frame: up to 38 months
3 secondary outcomes
Drug utilization of phenobarbital, propofol, dexmedetomidine, and ketamine in benzodiazepine-resistant alcohol withdrawal syndrome
Time frame: Up to 38 months
Effectiveness of phenobarbital, propofol, dexmedetomidine, and ketamine in benzodiazepine-resistant alcohol withdrawal
Time frame: Up to 38 months
Tolerability of phenobarbital, propofol, dexmedetomidine, and ketamine in benzodiazepine-resistant alcohol withdrawal
Time frame: Up to 38 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Withdrawal Syndrome, run by University of Pittsburgh at 1 site in United States.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Identify those risk factors predictive of benzodiazepine-resistant alcohol withdrawal syndrome (time frame: up to 38 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2016.