Psychomotor AgitationPhase 4NCT02612948
Quetiapine for Delirium Prophylaxis in High-risk Critically Ill Patients
A Phase 4 study testing Quetiapine in people with Psychomotor Agitation, run by University of Tennessee Graduate School of Medicine at 1 site in United States.
Trial summary
Scheduled, low-dose quetiapine is effective in preventing delirium in high-risk critically ill, trauma/surgical patients. Prophylaxis also reduced ventilator duration and ICU length of stay. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychomotor Agitation
- What is being tested?
- Quetiapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jun 2014
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Trauma/surgical patients admitted to the trauma/surgical ICU
Who cannot join
- sustained RASS of -4/-5 during the complete ICU admission
- presence of a condition preventing delirium assessment
- anticipated or known ICU length of stay of less than 48 hours
- taking antipsychotics prior to admission
- history of schizophrenia, epilepsy, parkinsonism, or levodopa treatment
- primary neurologic event/injury with GCS ≤ 9 during the first 48 hours of ICU
Show all 9Show fewer
- current treatment with a continuous infusion neuromuscular blocking agent
- pregnancy
- screened positive for delirium upon admission to the ICU.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee Medical Center
Knoxville, Tennessee, 37922
About this study
Scheduled, low-dose quetiapine is effective in preventing delirium in high-risk critically ill, trauma/surgical patients. Prophylaxis also reduced ventilator duration and ICU length of stay.
Read the detailed description
Objective: To evaluate the efficacy of scheduled quetiapine for delirium prophylaxis in critically ill, trauma/surgical patients identified as high-risk for delirium utilizing a validated prediction model.
Design: Prospective, open-label, single-center study. Setting: Trauma/surgical intensive care unit at an academic medical center. Patients: Eighty two adult trauma/surgical patients who were admitted to the intensive care unit and were at high-risk for the development of delirium (PRE-DELIRIC Score ≥50%, past medical history of dementia, past medical history of alcohol misuse, or past medical history of drug abuse).
Interventions: Patients were randomized by unit location to receive pharmacologic prophylaxis for delirium (quetiapine 12.5 mg every 12 hours) or no pharmacologic prophylaxis for delirium within forty-eight hours of admission to the intensive care unit.
Measurements: The primary end point was the incidence of delirium during admission to the intensive care unit (ICU). Secondary end points included time to onset of delirium, ICU and hospital lengths of stay, ICU and hospital mortality, duration of mechanical ventilation, and adverse events. Delirium was assessed using the confusion assessment method for the intensive care unit.
- Conditions
- Psychomotor Agitation
- Being tested
- Quetiapine
- Medical subject headings
- Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuetiapineDrug
Also called Seroquel
escalating dose to prevent delerium.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Standard care for delerium |
| Quetiapine | Active comparator | Quetiapine therapy was initiated at 12.5 mg twice daily a. After thefirst dose of quetiapine 12.5 mg, the regimen could then be adjusted by the rounding surgeon. If the surgeon felt benefit from receiving a higher dose of quetiapine the dose could then be increased. Quetiapine was discontinued if adverse events (torsades de pointes or other ventricular tachycardias) occurred. All patients receiving at least one dose of quetiapine were included in the final intention-to-treat analyses. All prescribing decisions were left to the discretion of the rounding surgeon and were not mandated as part of the study. Receives: Drug: Quetiapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delerium
ICU length of stay
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startNov 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychomotor AgitationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Daley, University of Tennessee Graduate School of Medicine
- Investigators
- Brian Daley, Principal investigator, University General Surgeons, P.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612948
- Sponsor's protocol ID
- 3709
- Status last verified
- Nov 2015
- First submitted
- 19 Nov 2015
- Last updated
- 24 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quetiapine for Delirium Prophylaxis in High-risk Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02612948
- Acronym / sponsor ID
- 3709
- Conditions
- Psychomotor Agitation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of Tennessee Graduate School of MedicineUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 24 Nov 2015 (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.
Scheduled, low-dose quetiapine is effective in preventing delirium in high-risk critically ill, trauma/surgical patients. Prophylaxis also reduced ventilator duration and ICU length of stay.
Detailed description
Objective: To evaluate the efficacy of scheduled quetiapine for delirium prophylaxis in critically ill, trauma/surgical patients identified as high-risk for delirium utilizing a validated prediction model.
Design: Prospective, open-label, single-center study. Setting: Trauma/surgical intensive care unit at an academic medical center. Patients: Eighty two adult trauma/surgical patients who were admitted to the intensive care unit and were at high-risk for the development of delirium (PRE-DELIRIC Score ≥50%, past medical history of dementia, past medical history of alcohol misuse, or past medical history of drug abuse).
Interventions: Patients were randomized by unit location to receive pharmacologic prophylaxis for delirium (quetiapine 12.5 mg every 12 hours) or no pharmacologic prophylaxis for delirium within forty-eight hours of admission to the intensive care unit.
Measurements: The primary end point was the incidence of delirium during admission to the intensive care unit (ICU). Secondary end points included time to onset of delirium, ICU and hospital lengths of stay, ICU and hospital mortality, duration of mechanical ventilation, and adverse events. Delirium was assessed using the confusion assessment method for the intensive care unit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Standard care for delerium |
| Quetiapine | Active comparator | Drug: QuetiapineQuetiapine therapy was initiated at 12.5 mg twice daily a. After thefirst dose of quetiapine 12.5 mg, the regimen could then be adjusted by the rounding surgeon. If the surgeon felt benefit from receiving a higher dose of quetiapine the dose could then be increased. Quetiapine was discontinued if adverse events (torsades de pointes or other ventricular tachycardias) occurred. All patients receiving at least one dose of quetiapine were included in the final intention-to-treat analyses. All prescribing decisions were left to the discretion of the rounding surgeon and were not mandated as part of the study. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Trauma/surgical patients admitted to the trauma/surgical ICU
Key exclusion criteria (9 listed)
- sustained RASS of -4/-5 during the complete ICU admission
- presence of a condition preventing delirium assessment
- anticipated or known ICU length of stay of less than 48 hours
- taking antipsychotics prior to admission
- history of schizophrenia, epilepsy, parkinsonism, or levodopa treatment
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 |
|---|---|---|
| QuetiapineAlso: Seroquelescalating dose to prevent delerium. | Drug | Quetiapine |
Primary outcome
Incidence of delerium
Time frame: One year
ICU length of stay
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 24 Nov 2015.
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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.
Brian Daley principal investigator
University General Surgeons, P.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quetiapine in people with Psychomotor Agitation, run by University of Tennessee Graduate School of Medicine 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 1 inclusion and 9 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 24 Nov 2015. 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.
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 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?
Incidence of delerium (time frame: One year). 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 24 Nov 2015.