Dexmedetomidine for Sepsis in ICU Randomized Evaluation Trial
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Ielogoties Reģistrēties
Saite tiek saglabāta starpliktuvē
StatussPabeigts
Sponsori
Wakayama Medical University
Līdzstrādnieki
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
KLĪNISKĀ IZPĒTE: NCT01760967
BioSeek: NCT01760967
Atslēgvārdi
Abstrakts
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.
Datumi
| Pēdējoreiz pārbaudīts: | 01/31/2017 |
| Pirmais iesniegtais: | 12/25/2012 |
| Paredzētā reģistrācija iesniegta: | 01/01/2013 |
| Pirmais izlikts: | 01/03/2013 |
| Pēdējais atjauninājums iesniegts: | 02/24/2017 |
| Pēdējā atjaunināšana ievietota: | 02/27/2017 |
| Faktiskais studiju sākuma datums: | 12/31/2012 |
| Paredzamais primārās pabeigšanas datums: | 12/31/2015 |
| Paredzamais pētījuma pabeigšanas datums: | 12/31/2015 |
Stāvoklis vai slimība
Sepsis
Iejaukšanās / ārstēšana
Drug: Dexmedetomidine
Fāze
Fāze 4
Roku grupas
| Roka | Iejaukšanās / ārstēšana |
|---|---|
| Active Comparator: Dexmedetomidine administer dexmedetomidine (0.1-0.7ug/kg/h) from the beginning of ICU treatment | |
| Active Comparator: non-Dexmedetomidine administer sedatives except Dexmedetomidine |
Atbilstības kritēriji
| Vecums, kas piemērots studijām | 20 Years Uz 20 Years |
| Dzimumi, kas ir piemēroti studijām | All |
| Pieņem veselīgus brīvprātīgos | Jā |
| Kritēriji | 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 |
Rezultāts
Primārie rezultāti
1. mortality [on 28 days]
mortality of patients on 28 days or on a day of discharge if patients are discharged earlier than 28 days
2. duration of mechanical ventilation [up to 28 days]
duration of mechanical ventilation in the ICU involving non-invasive ventilation
Sekundārie iznākuma mērījumi
1. length of stay in the ICU [up to 28 days]
2. length of stay in the hospital [up to 28 days]
3. Evaluation of restlessness and delirium [up to 28 days in the ICU]
evaluation of Richmond agitation-sedation scale (RASS) and Confusion Assessment Method for ICU patients (CAM-ICU)
4. Evaluation of cognitive function [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
5. Occurrence of arrythmia or myocardial ischemia [up to 28 days in the ICU]
6. Renal function [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
7. infection control [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
8. inflammation marker [for 14days]
Laboratory marker of inflammation (CRP, PCT) on 1,3,7,14 days
9. organ failure control [up to 28 days in the ICU]
Sequential Organ Failure Assessment (SOFA) score during in the ICU
10. coagulopathy control [for 14 days]
Disseminated Intravascular Coagulation (DIC) score by the Japanese Association for Acute Medicine during in the ICU
11. nutrition control [up to 28 days in the ICU]
daily energy intake by enteral nutrition
12. sedation control [up to 28 days in the ICU]
dose of sedative drugs and analgesic drugs during in the ICU
