Effects of Subanesthetic Isoflurane/Sevoflurane in 60% Oxygen on Clinical In-vitro Experimental Sepsis
Primary Purpose
Sepsis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
oxygen
Sevoflurane
Isoflurane
Sponsored by
About this trial
This is an interventional treatment trial for Sepsis
Eligibility Criteria
Inclusion Criteria:
- Human PBMCs were only isolated from the adult patients without sepsis/SIRS/infectious diseases.
- The plasma for induction of clinical in-vitro sepsis, was only isolated from adult patients with sepsis.
Exclusion Criteria:
- Patients who had been selected for other clinical trials in the 3 months before.
Sites / Locations
- Department of Anesthesiology, Xijing Hospital, Fourth Military Medical University,Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
oxygen plus isoflurane/sevoflurane
Arm Description
All human peripheral blood mononuclear cells (PBMCs) were from patients with non sepsis/non SIRS/non infection. The above cells were treated with oxygen or oxygen plus isoflurane/sevoflurane after stimulation of lipopolysaccharide/plasma from septic patients.
Outcomes
Primary Outcome Measures
Subcellular location of Nuclear Factor-KAPPA B p65 subunit
Secondary Outcome Measures
tumor necrosis factor-alpha
interleukin- 1 beta
interleukin 6
Full Information
NCT ID
NCT02185118
First Posted
June 20, 2014
Last Updated
July 6, 2014
Sponsor
Air Force Military Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT02185118
Brief Title
Effects of Subanesthetic Isoflurane/Sevoflurane in 60% Oxygen on Clinical In-vitro Experimental Sepsis
Official Title
In-vitro Experimental Study About Effects of Subanesthetic Isoflurane/Sevoflurane in 60% Oxygen on Clinical In-vitro Sepsis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Sepsis is a major cause of death in intensive care units. Despite the investigators improved understanding, which has reduced the risk of dying with sepsis, the number of people who die each year continues to increase due to an overall increase in the number of cases.In our previous study, the investigators have showed that 100% oxygen or 0.5 minimum alveolar concentration (MAC) isoflurane/sevoflurane in 60% oxygen protect mouse macrophage cell line against in-vitro sepsis induced by lipopolysaccharide (LPS).
In this study, the investigator hypothesized that treatment of 100% oxygen or 0.5 MAC isoflurane/sevoflurane in 60% oxygen protected against clinical in-vitro models of sepsis induced by LPS or plasma from septic patients.
Detailed Description
100% oxygen or 0.5 MAC isoflurane/sevoflurane in 60% oxygen would inhibit increases of tumor necrosis factor (TNF)-alpha, interleukin-1beta, interleukin-6 in the cell culture supernatant after stimulation of LPS or plasma from septic patients, and also inhibit the nuclear location of nuclear factor-kappa B p65 subunit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
oxygen plus isoflurane/sevoflurane
Arm Type
Experimental
Arm Description
All human peripheral blood mononuclear cells (PBMCs) were from patients with non sepsis/non SIRS/non infection.
The above cells were treated with oxygen or oxygen plus isoflurane/sevoflurane after stimulation of lipopolysaccharide/plasma from septic patients.
Intervention Type
Drug
Intervention Name(s)
oxygen
Other Intervention Name(s)
100% oxygen
Intervention Description
Clinical in-vitro sepsis was induced in peripheral blood monocytes of non-septic patients by lipopolysaccharide or plasma from septic patients.
Treatment of 100% oxygen or subanesthetic sevoflurane in 60% oxygen or subanesthetic isoflurane in 60% oxygen was performed on human peripheral blood mononuclear cells (PBMCs) stimulated by lipopolysaccharide or plasma from septic patients.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
subanesthetic sevoflurane in 60% oxygen
Intervention Description
Clinical in-vitro sepsis was induced in peripheral blood monocytes of non-septic patients by lipopolysaccharide or plasma from septic patients.
Treatment of 100% oxygen or subanesthetic sevoflurane in 60% oxygen was performed on human peripheral blood mononuclear cells (PBMCs) stimulated by lipopolysaccharide or plasma from septic patients.
Intervention Type
Drug
Intervention Name(s)
Isoflurane
Other Intervention Name(s)
subanesthetic isoflurane in 60% oxygen
Intervention Description
Clinical in-vitro sepsis was induced in peripheral blood monocytes of non-septic patients by lipopolysaccharide or plasma from septic patients.
Treatment of 100% oxygen or subanesthetic isoflurane in 60% oxygen was performed on human peripheral blood mononuclear cells (PBMCs) stimulated by lipopolysaccharide or plasma from septic patients.
Primary Outcome Measure Information:
Title
Subcellular location of Nuclear Factor-KAPPA B p65 subunit
Time Frame
within 10 hours after the intervention
Secondary Outcome Measure Information:
Title
tumor necrosis factor-alpha
Time Frame
within 10 hours after the intervention
Title
interleukin- 1 beta
Time Frame
within 10 hours after the intervention
Title
interleukin 6
Time Frame
within 10 hours after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Human PBMCs were only isolated from the adult patients without sepsis/SIRS/infectious diseases.
The plasma for induction of clinical in-vitro sepsis, was only isolated from adult patients with sepsis.
Exclusion Criteria:
Patients who had been selected for other clinical trials in the 3 months before.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lichao Hou, M.D., Ph.D.
Email
hou2001@fmmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lichao Hou, M.D., Ph.D.
Organizational Affiliation
Air Force Military Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology, Xijing Hospital, Fourth Military Medical University,
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
lichao Hou
Email
hou2001@fmmu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Effects of Subanesthetic Isoflurane/Sevoflurane in 60% Oxygen on Clinical In-vitro Experimental Sepsis
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