DeliriumPhase 4NCT02366299
Comparison of Dexmedetomidine and Propofol on the Delirium and Neuroinflammation in Patients With SIRS.
A Phase 4 study testing Dexmedetomidine and Propofol in people with Delirium, run by Moscow Regional Research and Clinical Institute (MONIKI).
Trial summary
Assessment of sedative effects of dexmedetomidine and propofol on the clinical course of delirium and neuroinflammation in patients with SIRS using CAM-ICU scale and protein S100b in serum. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Delirium
- What is being tested?
- Dexmedetomidine and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Dec 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presence of delirium
Who cannot join
- presence of Alzheimer's disease
- any mental disorder
- presence of cancer
About this study
Official title: Comparison of Sedative Effects of Dexmedetomidine and Propofol on the Clinical Course of Delirium and Neuroinflammation in Patients With SIRS.
Assessment of sedative effects of dexmedetomidine and propofol on the clinical course of delirium and neuroinflammation in patients with SIRS using CAM-ICU scale and protein S100b in serum.
- Conditions
- Delirium
- Being tested
- Dexmedetomidine, Propofol
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Dexdor
Treatment of delirium by dexmedetomidine i.v. infusion
PropofolDrug
Also called Diprivan
Treatment of delirium by Propofol i.v. infusion
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine | Active comparator | Treatment of delirium by dexmedetomidine i.v. infusion Receives: Drug: Dexmedetomidine |
| propofol | Active comparator | Treatment of delirium by propofol i.v. infusion Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
CAM-ICU scale
Measured: up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moscow Regional Research and Clinical Institute (MONIKI)
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Valery V. Likhvantsev, Professor, Moscow Regional Research and Clinical Institute (MONIKI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366299
- Sponsor's protocol ID
- D-P-SIRS-220115
- Status last verified
- Aug 2019
- First submitted
- 26 Jan 2015
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sedative Effects of Dexmedetomidine and Propofol on the Clinical Course of Delirium and Neuroinflammation in Patients With SIRS.
- ClinicalTrials.gov ID
- NCT02366299
- Acronym / sponsor ID
- D-P-SIRS-220115
- Conditions
- Delirium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Moscow Regional Research and Clinical Institute (MONIKI)Other government
- Study start
- Feb 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (actual)
- First posted
- 19 Feb 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.
Assessment of sedative effects of dexmedetomidine and propofol on the clinical course of delirium and neuroinflammation in patients with SIRS using CAM-ICU scale and protein S100b in serum.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine | Active comparator | Drug: DexmedetomidineTreatment of delirium by dexmedetomidine i.v. infusion |
| propofol | Active comparator | Drug: PropofolTreatment of delirium by propofol i.v. infusion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- presence of delirium
Key exclusion criteria (3 listed)
- presence of Alzheimer's disease
- any mental disorder
- presence of cancer
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 |
|---|---|---|
| DexmedetomidineAlso: DexdorTreatment of delirium by dexmedetomidine i.v. infusion | Drug | dexmedetomidine |
| PropofolAlso: DiprivanTreatment of delirium by Propofol i.v. infusion | Drug | propofol |
Primary outcome
CAM-ICU scale
Time frame: up to 5 days
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 14 Aug 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and Propofol in people with Delirium, run by Moscow Regional Research and Clinical Institute (MONIKI).
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 3 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 14 Aug 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. 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?
CAM-ICU scale (time frame: up to 5 days). 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 14 Aug 2019.