## Protocol Section
### Identification Module
**NCT ID:** NCT06437067

**Brief Title:** Study on Prognosis of Acute-on-chronic Liver Failure Complicated by Bacterial or Fungal Infection

**Official Title:** A Real-world Study on the Long-term Prognosis of Acute-on-chronic Liver Failure

#### Organization Study ID Info
**ID:** ACLF-I
#### Organization
**Class:** OTHER
**Full Name:** Tongji Hospital
### Status Module
#### Completion Date
**Date:** 2025-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-25

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-03-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-25
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Qin Ning

#### Responsible Party

**Investigator Affiliation:** Tongji Hospital

**Investigator Full Name:** Qin Ning

**Investigator Title:** Professor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### 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.

### Conditions Module

**Conditions:**

- Acute-On-Chronic Liver Failure

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 400

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** patients without bacterial or fungal infection

**Label:** non-infection group

#### Arm Group 2

**Description:** patients with bacterial infection

**Label:** bacterial infection group

#### Arm Group 3

**Description:** patients with fungal infection

**Label:** fungal infection group

### Outcomes Module

#### Primary Outcomes

**Description:** incidence rate of bacterial or fungal infection

**Measure:** incidence rate of bacterial or fungal infection

**Time Frame:** 28 days and 90 days

**Description:** mortality rate of bacterial or fungal infection

**Measure:** mortality rate of bacterial or fungal infection

**Time Frame:** 28 days and 90 days

#### Secondary Outcomes

**Description:** incidence rate of complications

**Measure:** incidence rate of complications

**Time Frame:** 28 days and 90 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. TBIL ≥ 12 mg/mL and INR ≥ 1.5
2. 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

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Inpatients with ACLF admitted to Tongji Hospital in Wuhan from March 2023 to June 2025.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** chentao_tjh@vip.sina.com

**Name:** Tao Chen, Professor

**Phone:** +8618971419301

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Wuhan

**Contacts:**

***Contact 1:***

- **Email:** qning@vip.sina.com

- **Name:** Qin Ning, PHD,MD

- **Phone:** +8602783662391

- **Role:** CONTACT

***Contact 2:***

- **Name:** Qin Ning, PHD,MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Tao Chen, PHD,MD

- **Role:** SUB_INVESTIGATOR

**Country:** China

**Facility:** Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

**State:** Hubei

**Status:** RECRUITING

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008107

- Term: Liver Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000017114

- Term: Liver Failure, Acute

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M19415

- Name: Liver Failure

- Relevance: HIGH

- As Found: Liver Failure

- ID: M25970

- Name: Hepatic Insufficiency

- Relevance: HIGH

- As Found: Liver Failure

- ID: M29168

- Name: End Stage Liver Disease

- Relevance: HIGH

- As Found: Chronic Liver Failure

- ID: M30498

- Name: Acute-On-Chronic Liver Failure

- Relevance: HIGH

- As Found: Acute on Chronic Liver Failure

- ID: M12136

- Name: Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M19431

- Name: Liver Failure, Acute

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000017093

- Term: Liver Failure

- ID: D000048550

- Term: Hepatic Insufficiency

- ID: D000058625

- Term: End Stage Liver Disease

- ID: D000065290

- Term: Acute-On-Chronic Liver Failure

### Intervention Browse Module - Browse Branches

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
