Safety Study of Dexmedetomidine in Septic Patients

Zhejiang University

Status: Completed

Conditions: Agitation; Sepsis

Treatments: Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT01976754

FirstzhejiangU

Details and patient eligibility

About

Septic patients in Intensive Care Unit always need mechanical ventilation and conscious-sedation. But the recommended dose 0.2-0.7μg/kg/h could not run well because of wide range. The purpose of this study is to find the effective dose of dexmedetomidine adult septic patients of mechanical ventilation .

Full description

Inclusion Criteria:

Age: between 18 years mechanical ventilation RASS≥2 A diagnosis of sepsis within 48 hours

Exclusion Criteria:

Cardiac disease Cardiac rhythm abnormalities liver dysfunction coma severe hypotension muscle relaxant users

Primary Outcome Measures:

Dose of dexmedetomidine

Secondary Outcome Measures:

RASS score Requirement for rescue intervention, RASS will be recorded per hour.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• intubated patients RASS≥2 A diagnosis of sepsis within 48h

Exclusion criteria

• Cardiac disease Cardiac rhythm abnormalities liver dysfunction coma severe hypotension muscle relaxant users

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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40 participants in 1 patient group

dexmedetomidine,sepsis,ED50

Other group

Description:

Intervention Name: dexmedetomidine dosage form: intravenous injection dosage：0.2-0.7μg/kg/h frequency: 1 duration:12 hours

Treatment:

Drug: Dexmedetomidine