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NCT01976754 Clinical Trial

Safety Study of Dexmedetomidine in Septic Patients

Sepsis Clinical Trial

Official title:
The Effective Dose of Dexmedetomidine for Moderate Sedation of Adult Intubated Septic Patients in the ICU.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01976754
Other study ID # FirstzhejiangU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2013
Est. completion date July 2015

Study information
Verified date February 2016
Source First Affiliated Hospital of Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 .

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date July 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
China Zhanqin Zhang Hangzhou Zhejiang

Sponsors (1)
Lead Sponsor Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dose of dexmedetomidine 12 hours
Secondary RASS score Requirement for rescue intervention, RASS will be recorded per hour. 1 hour
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