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RecruitingNCT06437067Updated May 31, 2024

Study on Prognosis of Acute-on-chronic Liver Failure Complicated by Bacterial or Fungal Infection

An observational study in Acute-On-Chronic Liver Failure, sponsored by Qin Ning. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-05-31.

Sponsored by Qin Ning · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Mar 2023; still recruiting 3 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The subjects of this study were inpatients with ACLF who were admitted to Tongji Hospital in Wuhan from March 2023 to June 2025. After patients were enrolled, The patient's general information (gender, age, past medical history, etc.), complications (ascites, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding, etc.), laboratory tests (CRP, PCT, INR, WBC, fungal/bacterial diagnostic tests, etc.), symptoms and signs at the time of infection, and at admission (D1), D4, D7, D14, D21, etc.) were recorded Save the blood separately. The patients were divided into fungal infection group, bacterial infection group and non-infection group according to the infection status after admission.

02

Conditions studied

  • Acute-On-Chronic Liver Failure
03

In context

Acute-On-Chronic Liver Failure

165 studies on the registry are indexed under Acute-On-Chronic Liver Failure; 60 are open to participants now.

This study's planned enrollment of 400 is above the median of 226 across 64 observational studies indexed under Acute-On-Chronic Liver Failure.

Browse Acute-On-Chronic Liver Failure studies →

Lead sponsor

Qin Ning is the lead sponsor of 11 studies on the registry; 5 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Inpatients with ACLF admitted to Tongji Hospital in Wuhan from March 2023 to June 2025.

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

  1. ≥ 12 mg/mL and ≥ 1.5
  2. Chronic

Exclusion criteria

Exclusion Criteria:

(1) \<18 or >80 years old; (2) primary hepatic or extrahepatic carcinoma; (3) with severe diseases of other organs or systems; (4) pregnancy; (5) imcomplete information

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
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • non-infection group

    patients without bacterial or fungal infection

  • bacterial infection group

    patients with bacterial infection

  • fungal infection group

    patients with fungal infection

06

What researchers measure

Primary outcomes

  1. incidence rate of bacterial or fungal infection

    incidence rate of bacterial or fungal infection

    Time frame: 28 days and 90 days

  2. mortality rate of bacterial or fungal infection

    mortality rate of bacterial or fungal infection

    Time frame: 28 days and 90 days

Secondary outcomes

  1. incidence rate of complications

    incidence rate of complications

    Time frame: 28 days and 90 days

07

Study locations

1 of 1 sites recruiting
  • Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei, China
    Recruiting
    • Qin Ning, PHD,MD · Contactqning@vip.sina.com · +8602783662391
    • Qin Ning, PHD,MD · Principal investigator
    • Tao Chen, PHD,MD · Sub investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06437067
Lead sponsor
Qin Ning
Responsible party
Qin Ning (Professor, Tongji Hospital) — Sponsor-investigator
First posted
May 31, 2024
Start date
Mar 1, 2023
Primary completion
Dec 31, 2024 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
May 31, 2024

Study contacts

Tao Chen, Professor
Contact
chentao_tjh@vip.sina.com
+8618971419301

Oversight

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

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