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Effects of Subanesthetic Isoflurane/Sevoflurane in 60% Oxygen on Clinical In-vitro Experimental Sepsis

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ClinicalTrials.gov Identifier: NCT02185118
Recruitment Status : Unknown
Verified July 2014 by Lichao Hou, Fourth Military Medical University.
Recruitment status was:  Recruiting
First Posted : July 9, 2014
Last Update Posted : July 9, 2014
Sponsor:
Information provided by (Responsible Party):
Lichao Hou, Fourth Military Medical University

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.


Condition or disease Intervention/treatment Phase
Sepsis Drug: oxygen Drug: Sevoflurane Drug: Isoflurane Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: In-vitro Experimental Study About Effects of Subanesthetic Isoflurane/Sevoflurane in 60% Oxygen on Clinical In-vitro Sepsis
Study Start Date : June 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: oxygen plus isoflurane/sevoflurane

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.

Drug: oxygen
  1. Clinical in-vitro sepsis was induced in peripheral blood monocytes of non-septic patients by lipopolysaccharide or plasma from septic patients.
  2. 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.
Other Name: 100% oxygen

Drug: Sevoflurane
  1. Clinical in-vitro sepsis was induced in peripheral blood monocytes of non-septic patients by lipopolysaccharide or plasma from septic patients.
  2. 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.
Other Name: subanesthetic sevoflurane in 60% oxygen

Drug: Isoflurane
  1. Clinical in-vitro sepsis was induced in peripheral blood monocytes of non-septic patients by lipopolysaccharide or plasma from septic patients.
  2. 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.
Other Name: subanesthetic isoflurane in 60% oxygen




Primary Outcome Measures :
  1. Subcellular location of Nuclear Factor-KAPPA B p65 subunit [ Time Frame: within 10 hours after the intervention ]

Secondary Outcome Measures :
  1. tumor necrosis factor-alpha [ Time Frame: within 10 hours after the intervention ]
  2. interleukin- 1 beta [ Time Frame: within 10 hours after the intervention ]
  3. interleukin 6 [ Time Frame: within 10 hours after the intervention ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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): NCT02185118


Contacts
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Contact: Lichao Hou, M.D., Ph.D. hou2001@fmmu.edu.cn

Locations
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China, Shaanxi
Department of Anesthesiology, Xijing Hospital, Fourth Military Medical University, Recruiting
Xi'an, Shaanxi, China, 710032
Contact: lichao Hou       hou2001@fmmu.edu.cn   
Sponsors and Collaborators
Fourth Military Medical University
Investigators
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Principal Investigator: Lichao Hou, M.D., Ph.D. Fourth Military Medical University

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Responsible Party: Lichao Hou, M.D., Ph.D, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT02185118     History of Changes
Other Study ID Numbers: NSFC-81171839
Chinese NSFC ( Other Grant/Funding Number: 30672041, 81171839 to Lichao Hou )
First Posted: July 9, 2014    Key Record Dates
Last Update Posted: July 9, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
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Sevoflurane
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Isoflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs