HBV InfectionHBVNCT02038088
The Effect of General Anesthesia Immunosuppressive on Hepatitis B Virus Replication
An observational study of HBV Infection, run by Lu KZ at 1 site in China.
Trial summary
The purpose of this study is to determine whether the general anesthesia immunosuppressive could effect hepatitis B Virus replication Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HBV Infection
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Jan 2015
- How long will I take part?
- 4 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with HBV infection receive surgery under general anesthesia
Who may be able to join
- American Society of Anesthesiologists（ASA） Ⅰ - Ⅱ;
- ability to compliance the research plan;
- volunteered and signed for the study ;
- HBsAg positive, no serious system disease (heart: New York Heart Association（NYHA） class Ⅰ - Ⅱ, lung: vital capacity（VC）% or maximal voluntary ventilation（MVV）%>71, forced expiratory volume at one second（FEV1.0）%>61, arterial oxygen saturation（SaO2）%>94, arterial partial pressure of oxygen（PaO2）>75 mmHg, arterial carbondioxide partial pressure（PaCO2）<45mmHg, liver:child-pugh class A - B and kidney: chronic kidney disease（CKD）stage 1-3);
- receive under general anesthesia (including gynecology, orthopedics,general surgery and urology department).
Who cannot join
- ASA>Ⅱ;
- tumor patients
- can't collaborate;
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology, Southwest Hospital Third Military Medical University
Chongqing, Chongqing Municipality, 400000
About this study
The purpose of this study is to determine whether the general anesthesia immunosuppressive could effect hepatitis B Virus replication
Read the detailed description
The change of immune state can influence HBV replication or elimination, it has been reported that a certain degree of immunosuppression occured after general anesthesia. In this study we detect the cytotoxic T lymphocyte(CTL) count and activity, interferon-γ(IFN-γ) and HBV-DNA content form the HBV patient who will accept general anesthesia. Our purpose is to evaluate the influence of general anesthesia immunosuppressive on HBV replication. If the results show that HBV-DNA quantity increases, so the patients might be given anti-HBV drugs or immune enhancer; otherwise it is indicated the general anesthesia immunosuppressive don't influence HBV replication.
- Conditions
- HBV Infection
- Keywords
- Need general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | intravenous inhalational anesthesia | |
| B | intravenous anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBV-DNA
collect blood samples 4 times with in the first 5 days after surgery:
the first time：before initiation of anesthesia; the second time：the first day after surgery; the third time：the third day after surgery; the forth time：the fifth day after surgery.
And outcome measure will be assessed with in 3 months when all the samples collected, and will be presented with in 2 months when outcome measure assessed .
Measured: with in the first 5 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HBV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 4 Days
Sponsor and investigators
- Lead sponsor
- Lu KZ
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lu KZ, Southwest Hospital, China
- Investigators
- Lu KZ, PhD, Study director, Department of Anesthesiology, Southwest Hospital Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038088
- Sponsor's protocol ID
- LKZ-GAHBV-01
- Acronym
- HBV
- Status last verified
- Jan 2015
- First submitted
- 13 Jan 2014
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Quan J, Chen X, Tang X, Liu X, Li J, Yi B, Li P, Lu K, Gu J. Effects of General Anesthesia on Changes of Serum Hepatitis B Virus-DNA Levels in Infected Patients Underwent Non-Hepatobiliary Minimally Invasive Surgery: A Pilot Observational Study. Infect Drug Resist. 2022 Nov 11;15:6631-6640. doi: 10.2147/IDR.S379350. eCollection 2022.
PubMed 36386418
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of General Anesthesia Immunosuppressive on Hepatitis B Virus Replication
- ClinicalTrials.gov ID
- NCT02038088
- Acronym / sponsor ID
- HBV / LKZ-GAHBV-01
- Conditions
- HBV Infection
- Keywords
- Need general anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Lu KZUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 16 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the general anesthesia immunosuppressive could effect hepatitis B Virus replication
Detailed description
The change of immune state can influence HBV replication or elimination, it has been reported that a certain degree of immunosuppression occured after general anesthesia. In this study we detect the cytotoxic T lymphocyte(CTL) count and activity, interferon-γ(IFN-γ) and HBV-DNA content form the HBV patient who will accept general anesthesia. Our purpose is to evaluate the influence of general anesthesia immunosuppressive on HBV replication. If the results show that HBV-DNA quantity increases, so the patients might be given anti-HBV drugs or immune enhancer; otherwise it is indicated the general anesthesia immunosuppressive don't influence HBV replication.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | –intravenous inhalational anesthesia |
| B | – | –intravenous anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with HBV infection receive surgery under general anesthesia
Key inclusion criteria (5 listed)
- American Society of Anesthesiologists（ASA） Ⅰ - Ⅱ;
- ability to compliance the research plan;
- volunteered and signed for the study ;
- HBsAg positive, no serious system disease (heart: New York Heart Association（NYHA） class Ⅰ - Ⅱ, lung: vital capacity（VC）% or maximal voluntary ventilation（MVV）%>71, forced expiratory volume at one second（FEV1.0）%>61, arterial oxygen saturation（SaO2）%>94, arterial partial pressure of oxygen（PaO2）>75 mmHg, arterial carbondioxide partial pressure（PaCO2）<45mmHg, liver:child-pugh class A - B and kidney: chronic kidney disease（CKD）stage 1-3);
- receive under general anesthesia (including gynecology, orthopedics,general surgery and urology department).
Key exclusion criteria (3 listed)
- ASA>Ⅱ;
- tumor patients
- can't collaborate;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HBV-DNA
Time frame: with in the first 5 days after surgery
collect blood samples 4 times with in the first 5 days after surgery: the first time：before initiation of anesthesia; the second time：the first day after surgery; the third time：the third day after surgery; the forth time：the fifth day after surgery. And outcome measure will be assessed with in 3 months when all the samples collected, and will be presented with in 2 months when outcome measure assessed .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2015.
- Derived from this study: PubMed 36386418Quan J, Chen X, Tang X, Liu X, Li J, Yi B, Li P, Lu K, Gu J. Effects of General Anesthesia on Changes of Serum Hepatitis B Virus-DNA Levels in Infected Patients Underwent Non-Hepatobiliary Minimally Invasive Surgery: A Pilot Observational Study. Infect Drug Resist. 2022 Nov 11;15:6631-6640. doi: 10.2147/IDR.S379350. eCollection 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lu KZ, PhD study director
Department of Anesthesiology, Southwest Hospital Third Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HBV Infection, run by Lu KZ at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBV-DNA (time frame: with in the first 5 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02038088, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2015.