AlcoholismPhase 4NCT00871039
Pilot Study Evaluating Stress Response and Immune Function in Mechanically Ventilated Patients With Alcohol Use Disorders Treated With Propofol or Midazolam
A Phase 4 study testing Propofol and Midazolam in people with Alcoholism and Respiration, Artificial, run by Virginia Commonwealth University at 2 sites in United States.
Trial summary
The aim of this study is to evaluate the effects of the sedatives propofol and midazolam on stress response and immune function in critically ill patients with alcohol use disorders who are undergoing mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholism, Respiration, Artificial
- What is being tested?
- Propofol and Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2009to Mar 2009
- 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
- Diagnosis of alcohol use disorders
- Need for invasive mechanical ventilation
- Need for continuous intravenous infusion of sedative(s)
Who cannot join
- Age < 18 years
- Pregnant women
- Prisoners
- Receiving propofol prior to randomization
- Patient experiencing active alcohol withdrawal
- Immunosuppression
Show all 11Show fewer
- Shock
- Attending physician does not feel patient is candidate to receive either propofol or midazolam
- Patient has contraindication(s) to receiving either propofol or midazolam
- Inability to enroll patient within 96 hours after initiation of mechanical ventilation
- Transfer from another intensive care unit
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Virginia Commonwealth University Medical Center (formerly known as Medical College of Virginia)
Richmond, Virginia, 23298
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298
About this study
Official title: Randomized Clinical Trial Comparing Propofol and Midazolam in Mechanically Ventilated Critically Ill Patients With Alcohol Use Disorders: An Open Label Pilot Study
The aim of this study is to evaluate the effects of the sedatives propofol and midazolam on stress response and immune function in critically ill patients with alcohol use disorders who are undergoing mechanical ventilation.
Read the detailed description
No detailed description
- Conditions
- Alcoholism, Respiration, Artificial
- Keywords
- Alcoholism, Mechanical ventilation
- Medical subject headings
- Alcoholism, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Patients to be sedated for up to 72 hours with study drug propofol
MidazolamDrug
Patients to be sedated for up to 72 hours with study drug midazolam
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Experimental | Patients to be sedated for up to 72 hours with study drug propofol Receives: Drug: Propofol |
| Midazolam | Experimental | Patients to be sedated for up to 72 hours with study drug midazolam Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress response and immune function.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2009
- Study completionMar 2009
Why it stopped: Due to logistical purposes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marjolein de Wit, M.D., Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871039
- Sponsor's protocol ID
- VCU IRB HM12035
- Status last verified
- Feb 2016
- First submitted
- 26 Mar 2009
- Last updated
- 1 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing Propofol and Midazolam in Mechanically Ventilated Critically Ill Patients With Alcohol Use Disorders: An Open Label Pilot Study
- ClinicalTrials.gov ID
- NCT00871039
- Acronym / sponsor ID
- VCU IRB HM12035
- Conditions
- Alcoholism, Respiration, Artificial
- Keywords
- Alcoholism, Mechanical ventilation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to logistical purposes
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 30 Mar 2009 (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 aim of this study is to evaluate the effects of the sedatives propofol and midazolam on stress response and immune function in critically ill patients with alcohol use disorders who are undergoing mechanical ventilation.
Detailed description
No detailed description
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Experimental | Drug: PropofolPatients to be sedated for up to 72 hours with study drug propofol |
| Midazolam | Experimental | Drug: MidazolamPatients to be sedated for up to 72 hours with study drug midazolam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of alcohol use disorders
- Need for invasive mechanical ventilation
- Need for continuous intravenous infusion of sedative(s)
Key exclusion criteria (11 listed)
- Age < 18 years
- Pregnant women
- Prisoners
- Receiving propofol prior to randomization
- Patient experiencing active alcohol withdrawal
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 |
|---|---|---|
| PropofolPatients to be sedated for up to 72 hours with study drug propofol | Drug | Propofol |
| MidazolamPatients to be sedated for up to 72 hours with study drug midazolam | Drug | Midazolam |
Primary outcome
Stress response and immune function.
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2016.
- Individual participant dataSharing planned: No
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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.
Marjolein de Wit, M.D. principal investigator
Virginia Commonwealth University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol and Midazolam in people with Alcoholism and Respiration, Artificial, run by Virginia Commonwealth University at 2 sites 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 3 inclusion and 11 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 1 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Stress response and immune function. (time frame: 6 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 1 Mar 2016.