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Dexmedetomidine for Sepsis in ICU Randomized Evaluation Trial

Information source: Wakayama Medical University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sepsis

Intervention: Dexmedetomidine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Wakayama Medical University

Official(s) and/or principal investigator(s):
Yu Kawazoe, Study Chair, Affiliation: Wakayama Medical University
Hitoshi Yamamura, doctor, Study Director, Affiliation: Osaka City University
Takeshi Morimoto, doctor, Study Director, Affiliation: Kinki University

Overall contact:
Yu Kawazoe, Phone: +81-73-441-0603, Email: ukz411@gmail.com

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.

Clinical Details

Official title: Effect of Dexmedetomidine on Mortality, Duration of Mechanical Ventilation and Multi-organ Function in Sepsis Patients Under Lighter Sedation by Randomized Control Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

mortality

duration of mechanical ventilation

Secondary outcome:

length of stay in the ICU

length of stay in the hospital

Evaluation of restlessness and delirium

Evaluation of cognitive function

Occurrence of arrythmia or myocardial ischemia

Renal function

infection control

inflammation marker

organ failure control

coagulopathy control

nutrition control

sedation control

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Yu Kawazoe, Phone: +81-73-441-0603, Email: ukz411@gmail.com

Wakayama Medical University, Wakayama, Japan; Recruiting
Yu Kawazoe, Phone: +81-73-441-0603, Email: ukz411@gmail.com
Additional Information

Starting date: January 2013
Last updated: February 7, 2013

Page last updated: August 23, 2015

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