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

July 6, 2014 updated by: Lichao Hou, Air Force Military Medical University, China

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Department of Anesthesiology, Xijing Hospital, Fourth Military Medical University,
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • 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 Names:
  • subanesthetic isoflurane in 60% oxygen

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Subcellular location of Nuclear Factor-KAPPA B p65 subunit
Time Frame: within 10 hours after the intervention
within 10 hours after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
tumor necrosis factor-alpha
Time Frame: within 10 hours after the intervention
within 10 hours after the intervention
interleukin- 1 beta
Time Frame: within 10 hours after the intervention
within 10 hours after the intervention
interleukin 6
Time Frame: within 10 hours after the intervention
within 10 hours after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Air Force Military Medical University, China

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lichao Hou, M.D., Ph.D., Air Force Military Medical University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NSFC-81171839
  • Chinese NSFC (Other Grant/Funding Number: 30672041, 81171839 to Lichao Hou)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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