DeliriumPhase 4NCT02117726
Impact of Various Sedation Regimens on the Incidence of Delirium
A Phase 4 study testing Dexmedetomidine,midazolam and Propofol,midazolam in people with Delirium, run by Shandong Provincial Hospital at 7 sites in China.
Trial summary
Sedation drugs that are commonly used in ICU in treatment of ARDS, includes propofol, midazolam and dexmedetomidine . Among these, both dexmedetomidine and propofol have been reported to be used together with midazolam in ICU and the combination of propofol and midazolam is most commonly used, but things follow… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Delirium
- What is being tested?
- Dexmedetomidine,midazolam and Propofol,midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 7 sitesChina
- Study dates
- May 2014to Dec 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects willing to give written informed consent.
- Mild, moderate or severe ARDS patients demanding invasive mechanical ventilation.
- Subjects whose expected time of mechanical ventilation is longer than 24 hours.
- Subjects aged between 18 and 70.
Who cannot join
- Subjects with extremely unstable circulation, whose SBP lower than 90mmHg after volume expansion or pressor agent treatment.
- Subjects with extremely unstable circulation, whose SBP lower than 90mmHg after volume expansion or pressor agent treatment.
- Subjects with heart rates less than 50 beats per minute.
- Subjects with second or third degree atrioventricular block.
- Subjects with serious cerebral injury, severe neurologic disorder (e.g acute stroke, uncontrolled epilepsy and severe dementia) or coma.
- Subjects with acute or severe liver disease (Child-Pugh class C), see attachment 2.
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- ARDS patients caused by pulmonary fibrosis or COPD.
- Subjects on all types hemodialysis.
- Subjects with neuromuscular system disease, alcohol withdrawal syndrome or mental disease before entrance of ICU.
- Subjects suspected of narcotic analgesics abusing.
- Subjects needing neuromuscular blocking agents (except intubation).
- Subjects allergic to investigational products or with other contraindication.
- Subjects who are breastfeeding or pregnant
- Subjects participated in other study within 30 days before entrance of ICU
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
The Second Hospital of Shandong University
Jinan, Shandong, 250033
Chengen Ma, +86 15153169727, chengen99@163.com
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272000
Haiwei Yang, Physician, +86 13518675416, yhw200465@126.com
Liaocheng Hospital
Liaocheng, Shandong, 252000
Tiejun Wu, physician, +86 13306352913, wtj0721@163.com
Linyi People's Hospital
Linyi, Shandong, 276000
Tingfa Zhou, +86 13013538061, zhoutingfa66@126.com
Affiliated Hospital of Weifang Medical University
Weifang, Shandong, 261031
Peirong Zhang, Physician, 15269600599, zhangpeirong@csco.org.cn
HeNan Tumor Hospital
Zhengzhou, Henan, 450000
Fang Xing, physician, 400-0371-818, xfsally2007@163.com
Fang Xing, Physician
Central Hospital of Zibo
Zibo, Shandong, 255000
Shifu Wang, Physician, 18678186866, wsficu@163.com
About this study
Official title: Impact of Various Sedation Regimens on the Incidence of Post-sedation Delirium in Patients Receiving Mechanical Ventilation
Sedation drugs that are commonly used in ICU in treatment of ARDS, includes propofol, midazolam and dexmedetomidine . Among these, both dexmedetomidine and propofol have been reported to be used together with midazolam in ICU and the combination of propofol and midazolam is most commonly used, but things follow include a high incidence rate of delirium, But the combination of midazolam and dexmedetomidine may have complementary advantages and could have be a better choice for sedation. In this study, we attempted to observe the effects of two different drug regimens on delirium incidence rates in severe ARDS patients' : midazolam and propofol vs propofol and dexmedetomidine .
- Conditions
- Delirium
- Being tested
- Dexmedetomidine,midazolam, Propofol,midazolam
- Keywords
- Sedation;, ARDS;, Mechanical ventilation, Hypnotics, Antianxiety Drugs, Causing, Adverse Effects, Therapeutic Use
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine,midazolamDrug
Propofol,midazolamDrug
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine,midazolam | Experimental | Slow injection of 2mg midazolam every minute and watching patients' reaction until attaining the target level of sedation;midazolam was maintained at 0.02~0.1mg/kg/h, for 24 hours.Dexmedetomidine will be added at 0.2~1.4μg/kg/h to maintain sedation.If target sedation level (RASS score) cannot be reached in maximum dose of dexmedetomidine, continuous intravenous infusion of midazolam could be used at 0.02~0.1mg/kg/h, until the target level is reached. Receives: Drug: Dexmedetomidine,midazolam |
| Propofol,midazolam | Active comparator | Slow injection of 2mg midazolam every minute and watching patients' reaction until attaining the target level of sedation;midazolam was maintained at 0.02~0.1mg/kg/h, for 24 hours.Propofol will be added at 0.3~4mg/kg/h to maintain sedation.If target sedation level (RASS score) cannot be reached in maximum dose of propofol, continuous intravenous infusion of midazolam could be used at 0.02~0.1mg/kg/h, until the target level is reached. Receives: Drug: Propofol,midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rates and duration of delirium
Incidence rates and duration of delirium within 14 days after initiation of sedation with dexmedetomidine or propofol
Measured: up to 15 days
Sedation interruption
Eye opening according to the voice orders, eye tracking, clenching fist and nodding are involved in assessment, patients could do 3 of those or more is deemed as conscious and taken in delirium assessment.
Measured: up to 5 days
Secondary outcomes (8)
Sedation therapy effect
The frequency of assessment whose score fall within the target range.
Measured: up to 7 days
Hospitalized days in ICU
Measured: up to 15 days
Death rates
Patients' death rates with a follow-up of 28 days
Measured: 28 days
Incidence rate of patients self-extubation
Measured: up to 7 days
Injection speed, total dose and injection of sedatives in different groups.
Measured: 7 days
Additional dose of fentanyl and midazolam
Measured: up to 7 days
Dosage of diuretic, antiemetic, hypoglycemic, beta-receptor antagonist and vasoactive agents.
Measured: up to 15 days
Variation degree of HR, RR, BP and SpO2
Measured: up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2015 (estimated)
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Wangchunting, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117726
- Sponsor's protocol ID
- ARDS2014
- Status last verified
- Jul 2014
- First submitted
- 16 Apr 2014
- Last updated
- 16 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Various Sedation Regimens on the Incidence of Post-sedation Delirium in Patients Receiving Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT02117726
- Acronym / sponsor ID
- ARDS2014
- Conditions
- Delirium
- Keywords
- Sedation;, ARDS;, Mechanical ventilation, Hypnotics, Antianxiety Drugs, Causing, Adverse Effects, Therapeutic Use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- May 2014
- Primary completion
- Dec 2015 (estimated)
- First posted
- 21 Apr 2014 (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.
Sedation drugs that are commonly used in ICU in treatment of ARDS, includes propofol, midazolam and dexmedetomidine . Among these, both dexmedetomidine and propofol have been reported to be used together with midazolam in ICU and the combination of propofol and midazolam is most commonly used, but things follow include a high incidence rate of delirium, But the combination of midazolam and dexmedetomidine may have complementary advantages and could have be a better choice for sedation. In this study, we attempted to observe the effects of two different drug regimens on delirium incidence rates in severe ARDS patients' : midazolam and propofol vs propofol and dexmedetomidine .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine,midazolam | Experimental | Drug: Dexmedetomidine,midazolamSlow injection of 2mg midazolam every minute and watching patients' reaction until attaining the target level of sedation;midazolam was maintained at 0.02~0.1mg/kg/h, for 24 hours.Dexmedetomidine will be added at 0.2~1.4μg/kg/h to maintain sedation.If target sedation level (RASS score) cannot be reached in maximum dose of dexmedetomidine, continuous intravenous infusion of midazolam could be used at 0.02~0.1mg/kg/h, until the target level is reached. |
| Propofol,midazolam | Active comparator | Drug: Propofol,midazolamSlow injection of 2mg midazolam every minute and watching patients' reaction until attaining the target level of sedation;midazolam was maintained at 0.02~0.1mg/kg/h, for 24 hours.Propofol will be added at 0.3~4mg/kg/h to maintain sedation.If target sedation level (RASS score) cannot be reached in maximum dose of propofol, continuous intravenous infusion of midazolam could be used at 0.02~0.1mg/kg/h, until the target level is reached. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects willing to give written informed consent.
- Mild, moderate or severe ARDS patients demanding invasive mechanical ventilation.
- Subjects whose expected time of mechanical ventilation is longer than 24 hours.
- Subjects aged between 18 and 70.
Key exclusion criteria (14 listed)
- Subjects with extremely unstable circulation, whose SBP lower than 90mmHg after volume expansion or pressor agent treatment.
- Subjects with extremely unstable circulation, whose SBP lower than 90mmHg after volume expansion or pressor agent treatment.
- Subjects with heart rates less than 50 beats per minute.
- Subjects with second or third degree atrioventricular block.
- Subjects with serious cerebral injury, severe neurologic disorder (e.g acute stroke, uncontrolled epilepsy and severe dementia) or coma.
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 |
|---|---|---|
| Dexmedetomidine,midazolam | Drug | Dexmedetomidine,midazolam |
| Propofol,midazolam | Drug | Propofol,midazolam |
Primary outcome
Incidence rates and duration of delirium
Time frame: up to 15 days
Incidence rates and duration of delirium within 14 days after initiation of sedation with dexmedetomidine or propofol
Sedation interruption
Time frame: up to 5 days
Eye opening according to the voice orders, eye tracking, clenching fist and nodding are involved in assessment, patients could do 3 of those or more is deemed as conscious and taken in delirium assessment.
8 secondary outcomes
Sedation therapy effect
Time frame: up to 7 days
Hospitalized days in ICU
Time frame: up to 15 days
Death rates
Time frame: 28 days
Incidence rate of patients self-extubation
Time frame: up to 7 days
Injection speed, total dose and injection of sedatives in different groups.
Time frame: 7 days
Additional dose of fentanyl and midazolam
Time frame: up to 7 days
Dosage of diuretic, antiemetic, hypoglycemic, beta-receptor antagonist and vasoactive agents.
Time frame: up to 15 days
Variation degree of HR, RR, BP and SpO2
Time frame: up to 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
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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.
7 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 Dexmedetomidine,midazolam and Propofol,midazolam in people with Delirium, run by Shandong Provincial Hospital at 7 sites in China.
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 14 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: status not confirmed, as of the sponsor's last update on 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rates and duration of delirium (time frame: up to 15 days). The study lists 2 primary outcomes in all. 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 16 Jul 2014.