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Dexmedetomidine for Sepsis in ICU Randomized Evaluation Trial (DESIRE)

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ClinicalTrials.gov Identifier: NCT01760967
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : February 28, 2017
Sponsor:
Collaborators:
Osaka City University
Hyogo College of Medicine
Osaka City General Hospital
National Hospital Organization Kyoto Medical Center
Saga University
Yamaguchi Grand Medical Center
Sapporo Medical University
Tohoku University
Hirosaki University
Kyoto Medical Center
Information provided by (Responsible Party):
Yu Kawazoe, Tohoku University

Tracking Information
First Submitted Date  ICMJE December 26, 2012
First Posted Date  ICMJE January 4, 2013
Last Update Posted Date February 28, 2017
Study Start Date  ICMJE January 2013
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2013)
  • mortality [ Time Frame: on 28 days ]
    mortality of patients on 28 days or on a day of discharge if patients are discharged earlier than 28 days
  • duration of mechanical ventilation [ Time Frame: up to 28 days ]
    duration of mechanical ventilation in the ICU involving non-invasive ventilation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2013)
  • length of stay in the ICU [ Time Frame: up to 28 days ]
  • length of stay in the hospital [ Time Frame: up to 28 days ]
  • Evaluation of restlessness and delirium [ Time Frame: up to 28 days in the ICU ]
    evaluation of Richmond agitation-sedation scale (RASS) and Confusion Assessment Method for ICU patients (CAM-ICU)
  • Evaluation of cognitive function [ Time Frame: on 28 days or on the day of discharge ]
    evaluation of Mini mental state examination (MMSE) on the 28 days or on a day of discharge if patients are discharged earlier than 28 days
  • Occurrence of arrythmia or myocardial ischemia [ Time Frame: up to 28 days in the ICU ]
  • Renal function [ Time Frame: up to 28 days in the ICU ]
    blood urea nitrogen (BUN), creatinine, estimated glomerular filtration rate (eGFR), daily urinary output, need of renal replacement therapy
  • infection control [ Time Frame: within 28 days until discharge ]
    Duration of antimicrobial agents use within 28 days or a day of discharge if patients are discharged earlier than 28 days
  • inflammation marker [ Time Frame: for 14days ]
    Laboratory marker of inflammation (CRP, PCT) on 1,3,7,14 days
  • organ failure control [ Time Frame: up to 28 days in the ICU ]
    Sequential Organ Failure Assessment (SOFA) score during in the ICU
  • coagulopathy control [ Time Frame: for 14 days ]
    Disseminated Intravascular Coagulation (DIC) score by the Japanese Association for Acute Medicine during in the ICU
  • nutrition control [ Time Frame: up to 28 days in the ICU ]
    daily energy intake by enteral nutrition
  • sedation control [ Time Frame: up to 28 days in the ICU ]
    dose of sedative drugs and analgesic drugs during in the ICU
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexmedetomidine for Sepsis in ICU Randomized Evaluation Trial
Official Title  ICMJE Effect of Dexmedetomidine on Mortality, Duration of Mechanical Ventilation and Multi-organ Function in Sepsis Patients Under Lighter Sedation by Randomized Control Trial
Brief Summary

Background:

Dexmedetomidine, a highly selective arfa2-adrenergic agonist, is known to be a unique sedative agent which causes less acute tolerance, drug addiction and withdrawal compared with gamma-aminobutyrate (GABA) agonists. Dexmedetomidine was approved for short-term ICU sedation in 2004 in Japan, and it has been used particularly for surgical ICU patients. In August 2010 dexmedetomidine was approved in Japan for sedation lasting more than 24 hours.

Recent evidence demonstrated that dexmedetomidine has organ protective effects including neuroprotection, cardioprotection, renal protection, gastrointestinal tract action, and anti-inflammatory action. Dexmedetomidine was shown to significantly decrease the infarct size in isolated rat hearts. Additionally, dexmedetomidine exhibited a preconditioning effect against ischemic injury in hippocampal slices, and this result was considered an apoptosis suppression effect of dexmedetomidine. Aydin C et al reported that dexmedetomidine enhanced the spontaneous contractions of the ileum in peritonitis rats compared with propofol and midazolam. Taniguchi and colleagues demonstrated that dexmedetomidine reduced high mortality rates and the plasma cytokine concentrations, interleukin-6 and tumor necrosis factor alpha in endotoxemic rats.

A meta-analysis has shown that perioperative alfa2-adrenergic agonists, including dexmedetomidine infusion, decreased cardiovascular events on patients undergoing cardiac surgery. Dexmedetomidine treated patients undergoing thoracotomy indicated increase in urine output, reduction in serum creatinine, and the suppression of diuretics in a randomized placebo-controlled double-blind study. Septic patients receiving dexmedetomidine had improved 28-day mortality rates compared with septic patients receiving lorazepam in a sub-group analysis of MENDS randomized controlled trial.

These positive effects of dexmedetomidine on the cardiovascular system, neurons, kidneys, gastrointestinal tract action, and an anti-inflammatory action, are expected to improve mortality in septic patients. However, large clinical research studies have not been conducted yet. We designed and conducted the DESIRE trial (DExmedetomidine for Sepsis in ICU Randomized Evaluation trial) to test a hypothesis that dexmedetomidine may improve clinical outcome and has these organ protective effects on septic patients.

Objective:

To determine whether dexmedetomidine improves clinical outcome and has organ protective effects on septic patients.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sepsis
Intervention  ICMJE Drug: Dexmedetomidine
intervention to administer dexmedetomidine or not
Study Arms  ICMJE
  • Active Comparator: Dexmedetomidine
    administer dexmedetomidine (0.1-0.7ug/kg/h) from the beginning of ICU treatment
    Intervention: Drug: Dexmedetomidine
  • Active Comparator: non-Dexmedetomidine
    administer sedatives except Dexmedetomidine
    Intervention: Drug: Dexmedetomidine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 29, 2016)
203
Original Estimated Enrollment  ICMJE
 (submitted: January 2, 2013)
200
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult
  • transferred to ICU
  • anticipation of a need for mechanical ventilation at least 24 hours

Exclusion Criteria:

  • sever chronic liver disease (Child B or C)
  • acute myocardial infarction, heart disease (NYHA 4)
  • Drug dependence, alcoholism
  • Psychological illness, severe cognitive dysfunction
  • patients who have allergy for dexmedetomidine
  • attending physician's decision
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01760967
Other Study ID Numbers  ICMJE DESIRE
UMIN000009665 ( Other Identifier: UMIN-CTR )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yu Kawazoe, Tohoku University
Study Sponsor  ICMJE Wakayama Medical University
Collaborators  ICMJE
  • Osaka City University
  • Hyogo College of Medicine
  • Osaka City General Hospital
  • National Hospital Organization Kyoto Medical Center
  • Saga University
  • Yamaguchi Grand Medical Center
  • Sapporo Medical University
  • Tohoku University
  • Hirosaki University
  • Kyoto Medical Center
Investigators  ICMJE
Study Chair: Yu Kawazoe Tohoku University
Study Director: Hitoshi Yamamura, doctor Hirosaki University
Study Director: Takeshi Morimoto, doctor Hyogo Medical University
PRS Account Wakayama Medical University
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP