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Safety Study of Dexmedetomidine in Septic Patients

Primary Purpose

Sepsis, Agitation

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Dexmedetomidine

About this trial

This is an interventional supportive care trial for Sepsis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Zhanqin Zhang

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

dexmedetomidine,sepsis,ED50

Arm Description

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

Outcomes

Primary Outcome Measures

Dose of dexmedetomidine

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01976754

First Posted

October 23, 2013

Last Updated

March 21, 2022

Sponsor

First Affiliated Hospital of Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT01976754

Brief Title

Safety Study of Dexmedetomidine in Septic Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

First Affiliated Hospital of Zhejiang University

4. Oversight

Data Monitoring Committee

Yes

5. 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 .

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sepsis, Agitation

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

dexmedetomidine,sepsis,ED50

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine

Other Intervention Name(s)

precedex

Intervention Description

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

Primary Outcome Measure Information:

Title

Dose of dexmedetomidine

Time Frame

12 hours

Secondary Outcome Measure Information:

Title

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

Time Frame

1 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

xiangming fang, PHD

Organizational Affiliation

First Affiliated Hospital of Zhejiang University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhanqin Zhang

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310000

Country

China

12. IPD Sharing Statement

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Safety Study of Dexmedetomidine in Septic Patients

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