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Not yet recruitingNCT06190002Updated Jan 5, 2024

Characteristics and Risk Factors for Invasive Fungal Infection With Acute-on-chronic Hepatitis B Liver Failure

An observational study in Acute-on-chronic Hepatitis B Liver Failure, sponsored by Qilu Hospital of Shandong University. Not yet recruiting. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-01-05.

Sponsored by Qilu Hospital of Shandong University · Observational

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 5 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
500
Ages
16 Years to 65 Years
Sex
All
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Study summary

This is a single-center retrospective study. The clinical data of patients with Acute-on-chronic Hepatitis B liver failure who were hospitalized in the Department of Hepatology, Qilu Hospital of Shandong University from January 2010 to July 2023 were collected.

Read the detailed description

The clinical data of patients with Acute-on-chronic Hepatitis B liver failure who were hospitalized in the Department of Hepatology, Qilu Hospital of Shandong University from January 2010 to July 2023 were collected, including age, gender, HBsAg,HBeAg, serum hepatitis B virus DNA, alanine aminotransferase, aspartate aminotransferase, Platelet, white blood cell,neutrophilic granulocyte percentage, neutrophile granulocyte, total bilirubin, creatinine, international normalized ratio,procalcitonin,globulin. prothrombin time activity, 1, 3 - beta glucan D test, Galactomannan test, sputum culture, imaging CT and other indicators. Our study followed up patients with Acute-on-chronic Hepatitis B liver failure with fungal infection during hospitalization to clarify the clinical characteristics and risk factors of fungal infection in the development of Acute-on-chronic Hepatitis B liver failure , and to provide clinical prevention and treatment recommendations for fungal infection in patients with Acute-on-chronic Hepatitis B liver failure . Thus, the prognosis of patients can be improved and the survival rate can be increased.

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Conditions studied

  • Acute-on-chronic Hepatitis B Liver Failure
03

In context

Hepatitis B, Chronic

895 studies on the registry are indexed under Hepatitis B, Chronic; 151 are open to participants now.

This study's planned enrollment of 500 is above the median of 400 across 206 observational studies indexed under Hepatitis B, Chronic.

Browse Hepatitis B, Chronic studies →

Lead sponsor

Qilu Hospital of Shandong University is the lead sponsor of 310 studies on the registry; 188 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The clinical data of patients with Acute-on-chronic hepatitis B liver failure hospitalized in the Department of Hepatology, Qilu Hospital of Shandong University from January 2010 to July 2023 were retrospectively collected. According to the inclusion criteria, 244 patients were finally included.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Acute liver function injury ≥5mg/dl(85umol/L) and (INR) ≥1.5 or PTA≤40% based on previously known chronic or compensated cirrhosis.
  • Combined with ascites and/or hepatic encephalopathy within 4 weeks.
  • HBsAg(+)>6 months

Exclusion criteria

Exclusion Criteria:

  • Patients died within 48 hours of admission or withdrew treatment.
  • Combined with liver cancer and other extrahepatic organ malignant tumors, rheumatic diseases, hyperthyroidism.
  • Age \<18 years old.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • invasive fungal infection group and non-invasive fungal infection group

    According to the presence or absence of invasive fungal infection, the patients were divided into invasive fungal infection group and non-invasive fungal infection group

06

What researchers measure

Primary outcomes

  1. Number of participants with invasive fungal infection

    Invasive candidiasis: isolation of Candida in one or more blood cultures (candidemia) or from normal sterile body fluids. Candida colonization: Candida was isolated in non-sterile fluid without infection. Probable invasive aspergillosis: Detection of Aspergillus by direct examination and/or culture of respiratory specimens under imaging that is consistent with the presence of pulmonary infection. Probable invasive fungal infection(IFI) was defined as the presence of clinical features including lower respiratory tract mycosis (nodules, halo sign, air crescent sign, or cavity on chest CT scan) and a positive aspergillus culture in sputum specimen. In fact, the definitions of probable IFI and IFI are the same, except that probable IFI lacks mycological evidence.

    Time frame: January 2010 to July 2023

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • De Pauw B, Walsh TJ, Donnelly JP, Stevens DA, Edwards JE, Calandra T, Pappas PG, Maertens J, Lortholary O, Kauffman CA, Denning DW, Patterson TF, Maschmeyer G, Bille J, Dismukes WE, Herbrecht R, Hope WW, Kibbler CC, Kullberg BJ, Marr KA, Munoz P, Odds FC, Perfect JR, Restrepo A, Ruhnke M, Segal BH, Sobel JD, Sorrell TC, Viscoli C, Wingard JR, Zaoutis T, Bennett JE; European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group; National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group. Revised definitions of invasive fungal disease from the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group. Clin Infect Dis. 2008 Jun 15;46(12):1813-21. doi: 10.1086/588660. PubMed 18462102 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2024; primary completion for May 2024, 4 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 17, 2023
First posted
Jan 5, 2024
StartEst.
Jan 20, 2024
Primary completionEst.
May 31, 2024
CompletionEst.
May 31, 2024
Last update
Jan 5, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06190002
Responsible party
Sponsor
First posted
Jan 5, 2024
Start date
Jan 20, 2024 (estimated)
Primary completion
May 31, 2024 (estimated)
Completion
May 31, 2024 (estimated)
Last update
Jan 5, 2024

Study contacts

Yu-Chen Fan, MD,PhD
Contact
fanyuchen@sdu.edu.cn
18560082065
Yu-Chen Fan, MD,PhD
study chair · Qilu Hospital of Shandong University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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