Status:
TERMINATED
Low-Dose Dexmedetomidine for Delirium Prevention in Mechanically Ventilated Septic Patients
Lead Sponsor:
Peking University First Hospital
Collaborating Sponsors:
China-Japan Friendship Hospital
Beijing Hospital
Conditions:
Adult
Intensive Care Unit
Eligibility:
All Genders
18+ years
Phase:
NA
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 anxiolyt...
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 ventila...
Eligibility Criteria
Inclusion
- Aged 18 years or older;
- Admitted to the ICU;
- With expected mechanical ventilation duration ≥12 hours;
- Meet the diagnostic criteria of sepsis (sepsis 3.0; patient with infection and a sequential organ failure assessment score ≥2).
Exclusion
- Refuse to participate in;
- Pregnancy;
- History of schizophrenia, epilepsy, parkinsonism, or myasthenia gravis;
- Inability to communicate (coma, profound dementia, or language barrier);
- Brain injury or neurosurgery;
- Left ventricular ejection fraction (LVEF) less than 30%, sick sinus syndrome, severe sinus bradycardia (\<50 beats per min \[bpm\]), or second degree or greater atrioventricular block without pacemaker;
- Serious hepatic dysfunction (Child-Pugh class C);
- Serious renal dysfunction (undergoing dialysis);
- With expected survival for no more than 24 hours;
- Allergic to dexmedetomidine;
- Other conditions that were considered unsuitable for study participation.
Key Trial Info
Start Date :
May 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2024
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04876937
Start Date
May 28 2021
End Date
March 2 2024
Last Update
August 5 2025
Active Locations (1)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034