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Safety Study of Dexmedetomidine in Septic Patients

Sponsor
First Affiliated Hospital of Zhejiang University (Other)
Overall Status
Completed
CT.gov ID
NCT01976754
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
21.9
Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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 .

Condition or Disease Intervention/Treatment Phase
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
The Effective Dose of Dexmedetomidine for Moderate Sedation of Adult Intubated Septic Patients in the ICU.
Study Start Date :
Sep 1, 2013
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Jul 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Other: dexmedetomidine,sepsis,ED50

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

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.
Other Names:
  • precedex

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Dose of dexmedetomidine [12 hours]

    Secondary Outcome Measures

    1. RASS score Requirement for rescue intervention, RASS will be recorded per hour. [1 hour]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhanqin Zhang Hangzhou Zhejiang China 310000

    Sponsors and Collaborators

    • First Affiliated Hospital of Zhejiang University

    Investigators

    • Principal Investigator: xiangming fang, PHD, First Affiliated Hospital of Zhejiang University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    zhanqin zhang, PHD candidate, First Affiliated Hospital of Zhejiang University
    ClinicalTrials.gov Identifier:
    NCT01976754
    Other Study ID Numbers:
    • FirstzhejiangU
    First Posted:
    Nov 6, 2013
    Last Update Posted:
    Mar 22, 2022
    Last Verified:
    Feb 1, 2016
    Additional relevant MeSH terms:
    Psychomotor Agitation
    Dexmedetomidine

    Study Results

    No Results Posted as of Mar 22, 2022