NCT02185118

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for not_applicable sepsis

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable sepsis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2014

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 9, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

July 9, 2014

Status Verified

July 1, 2014

Enrollment Period

4 years

First QC Date

June 20, 2014

Last Update Submit

July 6, 2014

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

  • Subcellular location of Nuclear Factor-KAPPA B p65 subunit

    within 10 hours after the intervention

Secondary Outcomes (3)

  • tumor necrosis factor-alpha

    within 10 hours after the intervention

  • interleukin- 1 beta

    within 10 hours after the intervention

  • interleukin 6

    within 10 hours after the intervention

Study Arms (1)

oxygen plus isoflurane/sevoflurane

EXPERIMENTAL

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: oxygenDrug: SevofluraneDrug: Isoflurane

Interventions

oxygenDRUG

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.

Also known as: 100% oxygen
oxygen plus isoflurane/sevoflurane
SevofluraneDRUG

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.

Also known as: subanesthetic sevoflurane in 60% oxygen
oxygen plus isoflurane/sevoflurane
IsofluraneDRUG

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.

Also known as: subanesthetic isoflurane in 60% oxygen
oxygen plus isoflurane/sevoflurane

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients who had been selected for other clinical trials in the 3 months before.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Xijing Hospital, Fourth Military Medical University,

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Sepsis

Interventions

OxygenSevofluraneIsoflurane

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGasesMethyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Lichao Hou, M.D., Ph.D.

    Air Force Military Medical University, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lichao Hou, M.D., Ph.D.

CONTACT

hou2001@fmmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D

Study Record Dates

First Submitted

June 20, 2014

First Posted

July 9, 2014

Study Start

June 1, 2014

Primary Completion

June 1, 2018

Study Completion

July 1, 2018

Last Updated

July 9, 2014

Record last verified: 2014-07

Locations

CN(1)