Actively Recruiting
Prospective Comparative Study of RECAM and RUCAM Scores for Diagnosing Drug-Induced Liver Injury in Hospitalized Patients
Led by Beijing Friendship Hospital · Updated on 2025-01-13
407
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with acute liver injury to compare two scoring systems, RECAM and RUCAM, for diagnosing drug-induced liver injury (DILI). The study involves 407 hospitalized patients at Beijing Friendship Hospital affiliated with Capital Medical University. The goal is to evaluate how well RECAM performs compared to RUCAM and to assess how consistently different doctors diagnose DILI using these scores. Participants admitted between March 2023 and September 2024 will have their demographic details, clinical symptoms, lab test results, imaging exams (including ultrasound, CT, and MRI), and liver biopsy reports collected. Three doctors will independently score each patient using RECAM and RUCAM to compare their diagnostic accuracy and agreement. Statistical analysis will also be done on the clinical, laboratory, imaging, and pathology data. During the study, patients' clinical and biochemical data will be closely reviewed to confirm the causes of liver injury. The main outcome is to determine whether RECAM is not inferior to RUCAM by July 2025. The study also compares the consistency between clinicians using both scoring systems. Patients will be followed up to confirm diagnoses, and their detailed medical information will be analyzed to improve understanding of drug-induced liver injury diagnosis.
CONDITIONS
Official Title
Prospective Comparative Validation Study of RUCAM and RECAM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Older than 18 years old
- Acute liver injury within 3 months of onset with biochemical criteria: ALT ≥5 times upper limit of normal; ALP ≥2 times upper limit of normal; or ALT ≥3 times upper limit of normal and total bilirubin ≥2 times upper limit of normal
- Clear history of medication including timing, drug names, doses, and reasons for use; detailed information on traditional Chinese medicine components if applicable
- Complete key data required for calculating RUCAM and RECAM scores
- Follow-up confirming the cause of acute liver injury as drug-induced liver injury or specified liver diseases such as acute viral hepatitis, alcoholic liver disease, autoimmune hepatitis, biliary diseases, hypoxic-ischemic hepatitis, or congestive liver disease
You will not qualify if you...
- Inability to accurately calculate incubation period due to unclear medication or illness onset dates
- Unclear identification of the causative drug, described only generally without specific names
- Missing biochemical data preventing assessment of liver biochemistry improvement after drug withdrawal
- Undetermined cause of acute liver injury
- Liver injury caused by acetaminophen overdose
- Toxic liver diseases such as mushroom poisoning or chemical poisonings
- Previous liver or bone marrow transplantation
- Pregnancy or lactation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Friendship Hospital
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
Research Team
X
Xinyan Zhao
Y
Yao Meng
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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