The Effect of General Anesthesia Immunosuppressive on Hepatitis B Virus Replication

HBV Infection Clinical Trial

— HBV  

Official title:

The Effect of General Anesthesia Immunosuppressive on Hepatitis B Virus Replication

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02038088
• Other study ID #: LKZ-GAHBV-01
• Status: Completed
• Phase: N/A
• First received: January 13, 2014
• Last updated: January 27, 2015
• Start date: January 2014
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: Southwest Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationChina: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to determine whether the general anesthesia immunosuppressive could effect hepatitis B Virus replication

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. American Society of Anesthesiologists(ASA) ? - ?;

2. ability to compliance the research plan;

3. volunteered and signed for the study ;

4. HBsAg positive, no serious system disease (heart: New York Heart Association(NYHA) class ? - ?, 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);

5. receive under general anesthesia (including gynecology, orthopedics,general surgery and urology department).

Exclusion Criteria:

1. ASA>?;

2. tumor patients

3. can't collaborate;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HBV Infection

Locations

Country	Name	City	State
China	Department of Anesthesiology, Southwest Hospital Third Military Medical University	ChongQing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Lu KZ

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 .	with in the first 5 days after surgery	Yes