Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04876937
Status:
UNKNOWN
Last Update Posted:
2022-04-20
First Post:
2021-05-03
Brief Title:
Low-Dose Dexmedetomidine for Delirium Prevention in Mechanically Ventilated Septic Patients
Sponsor:
Peking University First Hospital
Organization:
Peking University First Hospital
Study Overview
Official Title:
Low-Dose Dexmedetomidine for Delirium Prevention in Mechanically Ventilated Septic Patients in Intensive Care Unit a Multi-Center Randomized Double-Blind Placebo-Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Delirium is common in septic patients especially those receiving mechanical ventilation in the intensive care unit ICU Dexmedetomidine is a highly selective α2 adrenoreceptor agonist with anxiolytic sedative analgesic and anti-inflammatory effects Use of dexmedetomidine in mechanically ventilated ICU patients is associated with less delirium and improved outcomes However dexmedetomidine infusion produces dose-dependent bradycardia and hypotension these limited the use of dexmedetomidine in ICU patients This study is designed to test the hypothesis that low-dose dexmedetomidine infusion can also reduce delirium in mechanically ventilated ICU patients with sepsis
Detailed 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 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 α2 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 472 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 01 μgkgh 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 0-05 μgkgh 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 01-02 μgkgh 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
Dexmedetomidine is a highly selective α2 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 472 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 01 μgkgh 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 0-05 μgkgh 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 01-02 μgkgh 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None