Effects of Dexmedetomidine on Respiratory Function and Inflammatory Responses in Patient With Sepsis Undergoing Cleaning Focus of Infection

NCT ID: NCT02842437

Last Updated: 2016-07-22

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-12-31

Brief Summary

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The purpose of this study is to assess the efficacy of dexmedetomidine on lung protection in patient with sepsis undergoing cleaning focus of infection.

Detailed Description

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Sepsis is one of the most common, life-threatening medical conditions and is frequently complicated by organ failures, especially lung injury. It is well accepted that inflammatory reaction is the major cause of lung injury. Dexmedetomidine (Dex) is a novel α2-adrenoceptor agonist that is primarily used in surgical anesthesia and conscious-sedation. Recently, animal studies have shown that Dex plays an anti-inflammatory role, while it is not known whether Dex possesses any lung protective functions in patients with sepsis. Therefore, the aim of this study is to investigate the efficacy of Dex on lung protection in patient with sepsis undergoing cleaning focus of infection.

Conditions

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Organ Protection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dexmedetomidine

25 patients receive a loading infusion of dexmedetomidine (1ug/kg) for 10min follow by a maintenance infusion (0.5ug/kg·h) continued until the end of the surgery

Group Type EXPERIMENTAL

dexmedetomidine

Intervention Type DRUG

receive a loading infusion of dexmedetomidine (1ug/kg) for 10min follow by a maintenance infusion (0.5ug/kg·h) continued until the end of the surgery

Placebo

25 patients receive matching placebo (normal saline)

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type OTHER

receive matching placebo (equal volume of normal saline)

Interventions

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dexmedetomidine

receive a loading infusion of dexmedetomidine (1ug/kg) for 10min follow by a maintenance infusion (0.5ug/kg·h) continued until the end of the surgery

Intervention Type DRUG

normal saline

receive matching placebo (equal volume of normal saline)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* The patients with sepsis requiring abdominal cleaning focus of infection
* older than 18 years
* American Society of Anesthesiologists (ASA) physical status II-IV.

Exclusion Criteria

* Bradycardia
* Atrioventricular block
* Allergic to the drugs
* A history of respiratory disease
* Pregnancy or breast-feeding women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General Hospital of Ningxia Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhang Yonghai

Role: PRINCIPAL_INVESTIGATOR

General Hospital of Ningxia Medical University

Locations

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General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Site Status

Countries

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China

Central Contacts

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Ma Hanxiang

Role: CONTACT

+86-13519591508

Zhang Yonghai

Role: CONTACT

+86-15909508072

Facility Contacts

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Ma Hanxiang

Role: primary

+86-13519591508

Other Identifiers

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XM2015071

Identifier Type: -

Identifier Source: org_study_id

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