Safety Study of Dexmedetomidine in Septic Patients

NCT ID: NCT01976754

Last Updated: 2022-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-07-31

Brief Summary

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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

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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.

Conditions

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Sepsis Agitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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dexmedetomidine,sepsis,ED50

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

Group Type OTHER

Dexmedetomidine

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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precedex

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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zhanqin zhang

PHD candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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xiangming fang, PHD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Zhejiang University

Locations

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Zhanqin Zhang

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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FirstzhejiangU

Identifier Type: -

Identifier Source: org_study_id

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