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

Primary Purpose

Organ Protection

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
dexmedetomidine
normal saline
Sponsored by
General Hospital of Ningxia Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Organ Protection focused on measuring dexmedetomidine, sepsis, respiration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • General Hospital of Ningxia Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexmedetomidine

Placebo

Arm Description

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

25 patients receive matching placebo (normal saline)

Outcomes

Primary Outcome Measures

The Alveolar-Arterial Oxygen Difference
Arterial blood samples were sampled before anesthesia for the alveolar-arterial oxygen difference by using blood gas analyzer.
The Oxygenation Index
Arterial blood samples were sampled before anesthesia for the oxygenation index by using blood gas analyzer.
The Respiratory Index
Arterial blood samples were sampled before anesthesia for the respiratory index by using blood gas analyzer.
The Alveolar-Arterial Oxygen Difference
Arterial blood samples were sampled at 3 minutes after the skin is sutured for the alveolar-arterial oxygen difference by using blood gas analyzer.
The Oxygenation Index
Arterial blood samples were sampled at 3 minutes after the skin is sutured for the oxygenation index by using blood gas analyzer.
The Respiratory Index
Arterial blood samples were sampled at 3 minutes after the skin is sutured for the respiratory index by using blood gas analyzer.

Secondary Outcome Measures

Change of tumor necrosis factor-α before anesthesia and after dexmedetomidine or placebo infusion instantly
Blood samples were sampled before anesthesia and at 3 minutes after the skin is sutured for the serum tumor necrosis factor-α,which were analyzed by using enzyme linked immunosorbent assay (ELISA).
Change of interleukin-1β before anesthesia and after dexmedetomidine or placebo infusion instantly
Blood samples were sampled before anesthesia and at 3 minutes after the skin is sutured for the interleukin-1β,which were analyzed by using enzyme linked immunosorbent assay (ELISA).
Change of the lactic acid before anesthesia and after dexmedetomidine or placebo infusion instantly
Arterial blood samples were sampled before anesthesia and at 3 minutes after the skin is sutured for the lactic acid by using blood gas analyzer.

Full Information

First Posted
July 12, 2016
Last Updated
July 20, 2016
Sponsor
General Hospital of Ningxia Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02842437
Brief Title
Effects of Dexmedetomidine on Respiratory Function and Inflammatory Responses in Patient With Sepsis Undergoing Cleaning Focus of Infection
Official Title
Effects of Dexmedetomidine on Respiratory Function and Inflammatory Responses in Patient With Sepsis Undergoing Cleaning Focus of Infection
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
General Hospital of Ningxia Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Organ Protection
Keywords
dexmedetomidine, sepsis, respiration

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
25 patients receive matching placebo (normal saline)
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine
Intervention Description
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
Other
Intervention Name(s)
normal saline
Intervention Description
receive matching placebo (equal volume of normal saline)
Primary Outcome Measure Information:
Title
The Alveolar-Arterial Oxygen Difference
Description
Arterial blood samples were sampled before anesthesia for the alveolar-arterial oxygen difference by using blood gas analyzer.
Time Frame
Before anesthesia
Title
The Oxygenation Index
Description
Arterial blood samples were sampled before anesthesia for the oxygenation index by using blood gas analyzer.
Time Frame
Before anesthesia
Title
The Respiratory Index
Description
Arterial blood samples were sampled before anesthesia for the respiratory index by using blood gas analyzer.
Time Frame
Before anesthesia
Title
The Alveolar-Arterial Oxygen Difference
Description
Arterial blood samples were sampled at 3 minutes after the skin is sutured for the alveolar-arterial oxygen difference by using blood gas analyzer.
Time Frame
At 3 minutes after the skin is sutured
Title
The Oxygenation Index
Description
Arterial blood samples were sampled at 3 minutes after the skin is sutured for the oxygenation index by using blood gas analyzer.
Time Frame
At 3 minutes after the skin is sutured
Title
The Respiratory Index
Description
Arterial blood samples were sampled at 3 minutes after the skin is sutured for the respiratory index by using blood gas analyzer.
Time Frame
At 3 minutes after the skin is sutured
Secondary Outcome Measure Information:
Title
Change of tumor necrosis factor-α before anesthesia and after dexmedetomidine or placebo infusion instantly
Description
Blood samples were sampled before anesthesia and at 3 minutes after the skin is sutured for the serum tumor necrosis factor-α,which were analyzed by using enzyme linked immunosorbent assay (ELISA).
Time Frame
Before anesthesia and at 3 minutes after the skin is sutured
Title
Change of interleukin-1β before anesthesia and after dexmedetomidine or placebo infusion instantly
Description
Blood samples were sampled before anesthesia and at 3 minutes after the skin is sutured for the interleukin-1β,which were analyzed by using enzyme linked immunosorbent assay (ELISA).
Time Frame
Before anesthesia and at 3 minutes after the skin is sutured
Title
Change of the lactic acid before anesthesia and after dexmedetomidine or placebo infusion instantly
Description
Arterial blood samples were sampled before anesthesia and at 3 minutes after the skin is sutured for the lactic acid by using blood gas analyzer.
Time Frame
Before anesthesia and at 3 minutes after the skin is sutured

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ma Hanxiang
Phone
+86-13519591508
Email
mahanxiang@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhang Yonghai
Phone
+86-15909508072
Email
zhangyongha@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhang Yonghai
Organizational Affiliation
General Hospital of Ningxia Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ma Hanxiang
Phone
+86-13519591508
Email
mahanxiang@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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