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Effects of “Pre-ACLF screening” Kit Identification and Management Strategies for Very Early-Stage ACLF Patients on Improving Short-Term Adverse Outcomes

Effects of “Pre-ACLF screening” Kit Identification and Management Strategies for Very Early-Stage ACLF Patients on Improving Short-Term Adverse Outcomes: A Multicenter, Parallel, Randomized Controlled Study?

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104520
Enrollment
Unknown
Registered
2025-06-18
Start date
2025-06-30
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute-on-chronic Liver Failure (ACLF)

Interventions

Control group:standardized treatment according to the typical course of acute decompensation of liver cirrhosis.
Treatment group:“Pre-ACLF screening” Kit Identification and Management Strategies

Sponsors

Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age = 18 years and = 80 years; 2. Patients with chronic liver diseases including liver cirrhosis (diagnosed by CT/MRI imaging or based on past medical history); 3. Acute decompensation within 1 month (2-5 must still exist at the time of admission): 1) Upper gastrointestinal bleeding (black tarry stools + fecal occult blood [++]) 2) Manifest ascites (B-ultrasound depth > 5 cm) 3) Hepatic encephalopathy 4) Infection at a definite site 5) Jaundice (TB > 5 mg/dL); 4. The test result of "pre-ACLF screening" kit is greater than 0.23;

Exclusion criteria

Exclusion criteria: 1. Exclusion criteria: 1. Patients diagnosed with ACLF by the CATCH-LIFE criteria, that is, any of the following conditions: 1) TB > 20mg/dL; 2) Creatinine (Cr) > 2mg/DL or undergoing renal replacement therapy; 3) Hepatic encephalopathy = grade 3 and TB > 6mg/dL; 4) INR > 2.1; 5) SpO2/FiO2 = 214 or requiring mechanical ventilation; 6) Using vasoconstrictor drugs; 2. Presence of malignant tumors in the liver or in other extraliver organs; 3. Other severe comorbidities exist, such as heart failure, respiratory failure, chronic kidney disease, stroke or heart attack within the past six months, severe autoimmune diseases or metabolic disorders, etc. 4. Pregnant women and lactating women; 5. Long-term use of immunosuppressants due to non-liver disease causes.

Design outcomes

Primary

MeasureTime frame
90-day mortality;

Secondary

MeasureTime frame
Incidence rate of ACLF within 28 days;7d, 14d, 21d, 28d MELD score, MAP score, and Child-Pugh score;Mortality rates within 28 days, 90 days, and 180 days; Liver transplantation rates;The re-admission rate due to AD within 90 days after discharge;Incidence rates of adverse outcomes within 28 days and 90 days;28-day, 180-day mortality;

Countries

China

Contacts

Public ContactHai Li

Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine

haili_17@126.com+86 13818525494

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026