UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009665 |
|---|---|
| Receipt number | R000011277 |
| Scientific Title | Effect of dexmedetomidine on death and duration of mechanical ventilation in sepsis patients under lighter sedation randomized controlled trial |
| Date of disclosure of the study information | 2013/01/10 |
| Last modified on | 2017/03/22 10:17:29 |
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Basic information
Public title
Effect of dexmedetomidine on death and duration of mechanical ventilation in sepsis patients under lighter sedation randomized controlled trial
Acronym
Dexmedetomidine for sepsis in ICU Randomized Evaluation trial(DESIRE trial)
Scientific Title
Effect of dexmedetomidine on death and duration of mechanical ventilation in sepsis patients under lighter sedation randomized controlled trial
Scientific Title:Acronym
Dexmedetomidine for sepsis in ICU Randomized Evaluation trial(DESIRE trial)
Region
| Japan |
Condition
Condition
Sepsis patients receiving mechanical ventilation
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the efficacy of dexmedetomidine for sepsis patients in death and organ protection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
28-day mortality
Duration of mechanical ventilation
Key secondary outcomes
Length of stay in the ICU
Length of stay in the hospital
Evaluation of restlessness and delirium(Richmond Agitation-Sedation Scale[RASS], Confusion Assessment Method for ICU Patients[CAM-ICU])
Evaluation of cognitive function(Mini Mental State Examination[MMSE])
Occurrence of arrhythmia or myocardial ischemia
Renal function(BUN, Cre, eGFR), Daily urinary output, Need of renal replacement therapy
Duration of antimicrobial agents use
Laboratory marker of inflammation(C-Reactive Protein[CRP], procalcitonin)
Sequential Organ Failure Assessment(SOFA) score, Disseminated Intravascular Coagulation(DIC) score by the Japanese Association for Acute Medicine(JAAM)
Daily energy intake by enteral nutrition
Dose of sedative drugs and analgesic drugs, Use of antipsychotic drugs
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Sedation based on dexmedetomidine under mechanical ventilation
Interventions/Control_2
Sedation without dexmedetomidine under mechanical ventilation
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult ICU patients with sepsis who are considered to need mechanical ventilation for at least 24 hours
Key exclusion criteria
Severe chronic liver disease(Child B or C)
Acute myocardial infarction, heart disease(New York Heart Association[NYHA] 4)
Drug dependence, alcoholism
Psychological illness, severe cognitive dysfunction
Pregnant or lactating women
Patients who have allergy for dexmedetomidine
Attending physician's decision
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yu Kawazoe |
Organization
Tohoku University
Division name
Emergency Medicine
Zip code
Address
1-1 Seiryo-Cho, Aoba-Ku, Sendai-City, Miyagi-Prefecture 980-8574, JAPAN
TEL
022-717-7489
ukz411@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yu Kawazoe |
Organization
Tohoku University
Division name
Emergency Medicine
Zip code
Address
1-1 Seiryo-Cho, Aoba-Ku, Sendai-City, Miyagi-Prefecture 980-8574, JAPAN
TEL
022-717-7489
Homepage URL
ukz411@gmail.com
Sponsor or person
Institute
Research Organization for Sedation at Emergency and critical care
Institute
Department
Personal name
Funding Source
Organization
Research Organization for Sedation at Emergency and critical care
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT01760967
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
和歌山県立医科大学（和歌山県）、大阪市立大学（大阪府）、大阪市立総合医療センター（大阪府）、兵庫医科大学（兵庫県）、山口県立総合医療センター（山口県）、京都医療センター（京都府）、札幌医科大学附属病院（北海道）、島根大学附属病院（島根県）、佐賀大学附属病院（佐賀県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 10 | Day |
Related information
URL releasing protocol
http://jamanetwork.com/journals/jama/fullarticle/2612911
Publication of results
Published
Result
URL related to results and publications
http://jamanetwork.com/journals/jama/fullarticle/2612911
Number of participants that the trial has enrolled
Results
Question Does a sedation strategy with dexmedetomidine compared with no dexmedetomidine improve ventilator-free days and mortality among patients with sepsis requiring ventilation?
Findings In this randomized clinical trial that included 201 adults, treatment with dexmedetomidine compared with treatment without dexmedetomidine did not significantly improve ventilator-free days (20 days vs 18 days) or 28-day mortality (23% vs 31%; hazard ratio, 0.69).
Meaning Treatment with dexmedetomidine in patients with sepsis did not improve either ventilator-free days or 28-day mortality.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 08 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 15 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 15 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 29 | Day |
Last modified on
| 2017 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011277
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
