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

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.

Conditions

• Adult
• Intensive Care Unit
• Sepsis
• Mechanical Ventilation
• Delirium
• Dexmedetomidine

Interventions

DRUG

Dexmedetomidine

Dexmedetomidine is infused at a rate of 0.1-0.2 μg/kg/h (0.025-0.05 ml/kg/h) from study recruitment in the ICU during mechanical ventilation, for no more than 7 days.

DRUG

Placebo (normal saline)

Placebo (normal saline) is infused at a rate of 0.025-0.05 ml/kg/h from study recruitment in the ICU during mechanical ventilation, for no more than 7 days.

Sponsors & Collaborators

• China-Japan Friendship Hospital

  collaborator OTHER

• Beijing Hospital

  collaborator OTHER_GOV

• Beijing Friendship Hospital

  collaborator OTHER

• Beijing Shijitan Hospital, Capital Medical University

  collaborator OTHER

• Beijing Tongren Hospital

  collaborator OTHER

• Peking University First Hospital

  lead OTHER

Principal Investigators

• Dong-Xin Wang, MD,PhD · Peking University First Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-28

Primary Completion

2024-02-02

Completion

2024-03-02

Countries

• China

Study Locations