Trial record 2 of 220763 for:    ALL

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2016 by General Hospital of Ningxia Medical University
Sponsor:
Information provided by (Responsible Party):
General Hospital of Ningxia Medical University
ClinicalTrials.gov Identifier:
NCT02842437
First received: July 12, 2016
Last updated: July 20, 2016
Last verified: July 2016
  Purpose
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 Intervention
Organ Protection
Drug: dexmedetomidine
Other: normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Effects of Dexmedetomidine on Respiratory Function and Inflammatory Responses in Patient With Sepsis Undergoing Cleaning Focus of Infection

Resource links provided by NLM:


Further study details as provided by General Hospital of Ningxia Medical University:

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

  • The Oxygenation Index [ Time Frame: Before anesthesia ] [ Designated as safety issue: Yes ]
    Arterial blood samples were sampled before anesthesia for the oxygenation index by using blood gas analyzer.

  • The Respiratory Index [ Time Frame: Before anesthesia ] [ Designated as safety issue: Yes ]
    Arterial blood samples were sampled before anesthesia for the respiratory index by using blood gas analyzer.

  • The Alveolar-Arterial Oxygen Difference [ Time Frame: At 3 minutes after the skin is sutured ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: At 3 minutes after the skin is sutured ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: At 3 minutes after the skin is sutured ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Before anesthesia and at 3 minutes after the skin is sutured ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Before anesthesia and at 3 minutes after the skin is sutured ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Before anesthesia and at 3 minutes after the skin is sutured ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 50
Study Start Date: July 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02842437

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

Locations
China, Ningxia
General Hospital of Ningxia Medical University Recruiting
Yinchuan, Ningxia, China, 750004
Contact: Ma Hanxiang    +86-13519591508    mahanxiang@hotmail.com   
Sponsors and Collaborators
General Hospital of Ningxia Medical University
Investigators
Principal Investigator: Zhang Yonghai General Hospital of Ningxia Medical University
  More Information

Responsible Party: General Hospital of Ningxia Medical University
ClinicalTrials.gov Identifier: NCT02842437     History of Changes
Other Study ID Numbers: XM2015071 
Study First Received: July 12, 2016
Last Updated: July 20, 2016
Health Authority: China: Ministry of Science and Technology
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by General Hospital of Ningxia Medical University:
dexmedetomidine
sepsis
respiration

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on July 21, 2016