Low-Dose Dexmedetomidine for Delirium Prevention in Mechanically Ventilated Septic Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Adult
- Delirium
- Dexmedetomidine
- Intensive Care Unit
- Mechanical Ventilation
- Sepsis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Delirium is an acutely occurred and fluctuating disorder of consciousness, attention, and cognition. The occurrence of delirium is associated with worse outcomes including prolonged mechanical ventilation, prolonged length of stay in ICU and hospital, increased complications, higher in-hospital mort...
Delirium is an acutely occurred and fluctuating disorder of consciousness, attention, and cognition. The occurrence of delirium is associated with worse outcomes including prolonged mechanical ventilation, prolonged length of stay in ICU and hospital, increased complications, higher in-hospital mortality, and evaluated medical expenses. It is also associated with worse long-term outcomes including cognitive decline, worse quality of life, and shortened long-term survival. Dexmedetomidine is a highly selective ?2 adrenoreceptor agonist with anxiolytic, sedative, analgesic, and anti-inflammatory effects. Studies showed that use of dexmedetomidine is associated with less delirium in ICU patients. Potential mechanisms may include better sleep quality, less consumption of opioids and benzodiazepines, and suppressed inflammatory response. The incidence of sepsis in ICU patients is as high as 47.2%; 93% of septic patients relying on mechanical ventilation. Delirium is common in septic patients; the reported incidences varies from 20% to 50%. The incidence of delirium in critically ill patients with mechanical ventilation is up to 60-84%. However, the majority of mechanically ventilated ICU patients are sedated with propofol; only 10% of them are given dexmedetomidine. A main reason is that dexmedetomidine infusion is associated with dose-related bradycardia and hypotension. In a previous study, might-time low-dose dexmedetomidine infusion (0.1 ?g/kg/h) improved subjective sleep quality and reduced delirium in elderly patients admitted to ICU after surgery. In another study of ICU patients receiving mechanical ventilation, low-dose dexmedetomidine infusion (0-0.5 ?g/kg/h) based on protocol sedation also reduced delirium and shortened mechanical ventilation without increasing adverse events. We hypothesized that, in ICU septic patients with mechanical ventilation, low-dose dexmedetomidine infusion (0.1-0.2 ?g/kg/h) might also reduce delirium. The purpose of this study is to investigate the effect of low-dose dexmedetomidine infusion on incidence of delirium in ICU septic patients with mechanical ventilation.
Tracking Information
- NCT #
- NCT04876937
- Collaborators
- China-Japan Friendship Hospital
- Beijing Hospital
- Beijing Friendship Hospital
- Beijing Shijitan Hospital, Capital Medical University
- Beijing Tongren Hospital
- Investigators
- Principal Investigator: Dong-Xin Wang, MD,PhD Peking University First Hospital