Dexmedetomidine for Sepsis in ICU Randomized Evaluation Trial (DESIRE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Wakayama Medical University
Sponsor:
Collaborators:
Kinki University
Osaka City University
Hyogo College of Medicine
Osaka City General Hospital
National Hospital Organization Kyoto Medical Center
Shimane University
Saga University
Yamaguchi Grand Medical Center
Sapporo Medical University
Information provided by (Responsible Party):
Yu Kawazoe, Wakayama Medical University
ClinicalTrials.gov Identifier:
NCT01760967
First received: December 26, 2012
Last updated: February 7, 2013
Last verified: February 2013

December 26, 2012
February 7, 2013
January 2013
December 2015   (final data collection date for primary outcome measure)
  • mortality [ Time Frame: on 28 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • length of stay in the hospital [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
  • Evaluation of restlessness and delirium [ Time Frame: up to 28 days in the ICU ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Renal function [ Time Frame: up to 28 days in the ICU ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Laboratory marker of inflammation (CRP, PCT) on 1,3,7,14 days
  • organ failure control [ Time Frame: up to 28 days in the ICU ] [ Designated as safety issue: No ]
    Sequential Organ Failure Assessment (SOFA) score during in the ICU
  • coagulopathy control [ Time Frame: for 14 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    daily energy intake by enteral nutrition
  • sedation control [ Time Frame: up to 28 days in the ICU ] [ Designated as safety issue: No ]
    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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Not Provided
December 2015   (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
Both
20 Years and older
No
Contact: Yu Kawazoe +81-73-441-0603 ukz411@gmail.com
Contact: Kyohei Miyamoto +81-73-441-0603 go.go.kyohei.miyamoto@gmail.com
Japan
 
NCT01760967
DESIRE, UMIN000009665
Yes
Yu Kawazoe, Wakayama Medical University
Wakayama Medical University
  • Kinki University
  • Osaka City University
  • Hyogo College of Medicine
  • Osaka City General Hospital
  • National Hospital Organization Kyoto Medical Center
  • Shimane University
  • Saga University
  • Yamaguchi Grand Medical Center
  • Sapporo Medical University
Study Chair: Yu Kawazoe Wakayama Medical University
Study Director: Hitoshi Yamamura, doctor Osaka City University
Study Director: Takeshi Morimoto, doctor Kinki University
Wakayama Medical University
February 2013

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