UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of dexmedetomidine on death and duration of mechanical ventilation in sepsis patients under lighter sedation randomized controlled trial
Title of the study (Brief title)	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	Yu Kawazoe
Organization	Tohoku University
Division name	Emergency Medicine
Address	1-1 Seiryo-Cho, Aoba-Ku, Sendai-City, Miyagi-Prefecture 980-8574, JAPAN
TEL	022-717-7489
Email	ukz411@gmail.com

Public contact
Name of contact person	Yu Kawazoe
Organization	Tohoku University
Division name	Emergency Medicine
Address	1-1 Seiryo-Cho, Aoba-Ku, Sendai-City, Miyagi-Prefecture 980-8574, JAPAN
TEL	022-717-7489
Homepage URL
Email	ukz411@gmail.com

Sponsor
Institute	Research Organization for Sedation at Emergency and critical care
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 08 Month 08 Day
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

Related information
URL releasing protocol	http://jamanetwork.com/journals/jama/fullarticle/2612911
Publication of results	Published
URL releasing results	http://jamanetwork.com/journals/jama/fullarticle/2612911
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011277