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Dexmedetomidine for Sepsis in ICU Randomized Evaluation Trial (DESIRE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01760967
First Posted: January 4, 2013
Last Update Posted: February 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
December 26, 2012
January 4, 2013
February 28, 2017
January 2013
January 2016   (Final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01760967 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Dexmedetomidine for Sepsis in ICU Randomized Evaluation Trial
Effect of Dexmedetomidine on Mortality, Duration of Mechanical Ventilation and Multi-organ Function in Sepsis Patients Under Lighter Sedation by Randomized Control Trial

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Sepsis
Drug: Dexmedetomidine
intervention to administer dexmedetomidine or not
  • 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
Kawazoe Y, Miyamoto K, Morimoto T, Yamamoto T, Fuke A, Hashimoto A, Koami H, Beppu S, Katayama Y, Itoh M, Ohta Y, Yamamura H; Dexmedetomidine for Sepsis in Intensive Care Unit Randomized Evaluation (DESIRE) Trial Investigators. Effect of Dexmedetomidine on Mortality and Ventilator-Free Days in Patients Requiring Mechanical Ventilation With Sepsis: A Randomized Clinical Trial. JAMA. 2017 Apr 4;317(13):1321-1328. doi: 10.1001/jama.2017.2088.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
203
January 2016
January 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01760967
DESIRE
UMIN000009665 ( Other Identifier: UMIN-CTR )
Yes
Not Provided
Not Provided
Yu Kawazoe, Tohoku University
Wakayama Medical University
  • 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
Study Chair: Yu Kawazoe Tohoku University
Study Director: Hitoshi Yamamura, doctor Hirosaki University
Study Director: Takeshi Morimoto, doctor Hyogo Medical University
Wakayama Medical University
February 2017

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