Safety Study of Dexmedetomidine in Septic Patients

N/ACompletedNCT01976754

First Affiliated Hospital of Zhejiang University40 enrolled

Overview

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 .

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Sepsis Agitation

Interventions

DexmedetomidineDRUG

Septic patients are randomly received 1 of 6 doses( 0.2,0.3,0.4,0.5,0.6,0.7μg/kg/h) dexmedetomidine.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Zhanqin Zhang

Hangzhou, Zhejiang, China

Outcomes

Primary Outcomes

Dose of dexmedetomidine

Time frame: 12 hours

Secondary Outcomes

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

Time frame: 1 hour

Data from ClinicalTrials.gov

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