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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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ClinicalTrials.gov Identifier: NCT02842437
Recruitment Status : Unknown
Verified July 2016 by General Hospital of Ningxia Medical University.
Recruitment status was:  Not yet recruiting
First Posted : July 22, 2016
Last Update Posted : July 22, 2016
Sponsor:
Information provided by (Responsible Party):
General Hospital of Ningxia Medical University

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.

Condition or disease Intervention/treatment Phase
Organ Protection Drug: dexmedetomidine Other: normal saline Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effects of Dexmedetomidine on Respiratory Function and Inflammatory Responses in Patient With Sepsis Undergoing Cleaning Focus of Infection
Study Start Date : July 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
Experimental: 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
Drug: 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

Placebo Comparator: Placebo
25 patients receive matching placebo (normal saline)
Other: normal saline
receive matching placebo (equal volume of normal saline)




Primary Outcome Measures :
  1. The Alveolar-Arterial Oxygen Difference [ Time Frame: Before anesthesia ]
    Arterial blood samples were sampled before anesthesia for the alveolar-arterial oxygen difference by using blood gas analyzer.

  2. The Oxygenation Index [ Time Frame: Before anesthesia ]
    Arterial blood samples were sampled before anesthesia for the oxygenation index by using blood gas analyzer.

  3. The Respiratory Index [ Time Frame: Before anesthesia ]
    Arterial blood samples were sampled before anesthesia for the respiratory index by using blood gas analyzer.

  4. The Alveolar-Arterial Oxygen Difference [ Time Frame: At 3 minutes after the skin is sutured ]
    Arterial blood samples were sampled at 3 minutes after the skin is sutured for the alveolar-arterial oxygen difference by using blood gas analyzer.

  5. The Oxygenation Index [ Time Frame: At 3 minutes after the skin is sutured ]
    Arterial blood samples were sampled at 3 minutes after the skin is sutured for the oxygenation index by using blood gas analyzer.

  6. The Respiratory Index [ Time Frame: At 3 minutes after the skin is sutured ]
    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 :
  1. Change of tumor necrosis factor-α before anesthesia and after dexmedetomidine or placebo infusion instantly [ Time Frame: Before anesthesia and at 3 minutes after the skin is sutured ]
    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).

  2. Change of interleukin-1β before anesthesia and after dexmedetomidine or placebo infusion instantly [ Time Frame: Before anesthesia and at 3 minutes after the skin is sutured ]
    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).

  3. Change of the lactic acid before anesthesia and after dexmedetomidine or placebo infusion instantly [ Time Frame: Before anesthesia and at 3 minutes after the skin is sutured ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842437


Contacts
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Contact: Ma Hanxiang +86-13519591508 mahanxiang@hotmail.com
Contact: Zhang Yonghai +86-15909508072 zhangyongha@hotmail.com

Locations
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China, Ningxia
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China, 750004
Contact: Ma Hanxiang    +86-13519591508    mahanxiang@hotmail.com   
Sponsors and Collaborators
General Hospital of Ningxia Medical University
Investigators
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Principal Investigator: Zhang Yonghai General Hospital of Ningxia Medical University
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Responsible Party: General Hospital of Ningxia Medical University
ClinicalTrials.gov Identifier: NCT02842437    
Other Study ID Numbers: XM2015071
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: July 22, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by General Hospital of Ningxia Medical University:
dexmedetomidine
sepsis
respiration
Additional relevant MeSH terms:
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Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action