Study on Prognosis of Acute-on-chronic Liver Failure Comp... | NCT06437067

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

NCT06437067

Sponsor

Qin Ning

Status

Unknown status

Last Update Posted

May 31, 2024Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Acute-On-Chronic Liver Failure

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2023Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Jun 30, 2025Estimated

First Submitted Date

May 25, 2024

First Submission Date that Met QC Criteria

May 25, 2024

First Posted Date

May 31, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2024

Last Update Posted Date

May 31, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
non-infection group		patients without bacterial or fungal infection
bacterial infection group		patients with bacterial infection
fungal infection group		patients with fungal infection

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence rate of bacterial or fungal infection	incidence rate of bacterial or fungal infection	28 days and 90 days
mortality rate of bacterial or fungal infection	mortality rate of bacterial or fungal infection	28 days and 90 days

Secondary Outcomes

Measure	Description	Time Frame
incidence rate of complications	incidence rate of complications	28 days and 90 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

TBIL ≥ 12 mg/mL and INR ≥ 1.5
Chronic hepatitis B

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tao Chen, Professor	Contact	+8618971419301		chentao_tjh@vip.sina.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Recruiting	Wuhan	Hubei		China

Condition Browse Module

MeSH Terms

ID	Term
D065290	Acute-On-Chronic Liver Failure

Ancestor Terms

ID	Term
D017114	Liver Failure, Acute
D017093	Liver Failure
D048550	Hepatic Insufficiency
D008107	Liver Diseases

Browse Leaves

Not provided

Browse Branches

Not provided