Low-Dose Dexmedetomidine for Delirium Prevention in Mechanically Ventilated Septic Patients

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University First Hospital
• Collaborators: Beijing Friendship Hospital; Beijing Hospital; Beijing Shijitan Hospital, Capital Medical University; Beijing Tongren Hospital; China-Japan Friendship Hospital
• Treatments: Dexmedetomidine

Criteria

Inclusion Criteria:

1. Aged 18 years or older;

2. Admitted to the ICU;

3. With expected mechanical ventilation duration ≥12 hours;

4. Meet the diagnostic criteria of sepsis (sepsis 3.0; patient with infection and a sequential organ failure assessment score ≥2).

Exclusion Criteria:

1. Refuse to participate in;

2. Pregnancy;

3. History of schizophrenia, epilepsy, parkinsonism, or myasthenia gravis;

4. Inability to communicate (coma, profound dementia, or language barrier);

5. Brain injury or neurosurgery;

6. 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;

7. Serious hepatic dysfunction (Child-Pugh class C);

8. Serious renal dysfunction (undergoing dialysis);

9. With expected survival for no more than 24 hours;

10. Allergic to dexmedetomidine;

11. Other conditions that were considered unsuitable for study participation.