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Clinical Trials in China / NCT06771011
Recruiting Observational

Prospective Comparative Validation Study of RUCAM and RECAM

NCT06771011 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Friendship Hospital
Phase
Observational
Started
2023-05-01
Last updated
2025-01-13

Condition(s) studied

Drug Induced Liver Injury

Study summary

A total of 407 hospitalized patients with acute liver injury in Beijing Friendship Hospital Affiliated to Capital Medical University were enrolled. The clinical information, biochemical examination, imageological examination (ultrasound, CT, MRI) and liver biopsy pathology of patients with acute liver injury will be collected. The diagnostic efficacy of RECAM and RUCAM in the diagnosis of DILI will be compared, and the consistency of different clinicians in the diagnosis of DILI using RECAM and RUCAM scores will also be compared.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: 1. Older than 18 years old 2. Acute liver injury within 3 months of onset and biochemical meeting one of the following criteria: ALT≥5 ULN; ALP≥2 ULN; ALT≥3 ULN and TBil≥2 ULN 3. The patients had a clear history of medication: the time from medication to onset, the time from drug withdrawal to onset, the time of the first laboratory test and the peak laboratory test, the reason for taking medication, the name of the drug, the dose of the drug, and the frequency. If the causative drug includes traditional Chinese medicine, the specific name of all the components or patent Chinese medicine in the prescription, a single drug or single component, or the main ingredient in the prescription causing liver injury should be provided 4. All the key data for RUCAM and RECAM can accurately be contained. 5. Follow-up outcomes confirmed that the cause of the acute liver injury was any of the following liver diseases: Drug-induced liver injury, acute viral hepatitis (including acute viral hepatitis A, acute viral hepatitis B or acute exacerbation of chronic hepatitis B, acute viral hepatitis E), alcoholic liver disease, autoimmune hepatitis, biliary calculi, biliary obstruction, hypoxic-ischemic hepatitis, congestive liver disease and other liver diseases Exclusion Criteria: 1. The incubation period cannot be accurately calculated: the dates of starting medication, stopping medication, and onset of illness cannot be accurately described, resulting in the inability to calculate the incubation period 2. Can not be clear about the pathogenic drug: the pathogenic drug is only described as "traditional Chinese medicine, cold medicine, antipyretic medicine", but cannot be clear about what kind of medicine 3. Missing biochemical data, resulting in inability to assess the time of 50% decrease in liver biochemistry (ALT or ALP, TBIL) from the peak after drug withdrawal 4. The cause of the patient's acute liver injury could not be determined 5. Acetaminophen liver injury 6. Toxic liver disease, such as mushroom poisoning caused liver damage, chemical poisons (such as paint, etc.) liver damage 7. Previous liver transplantation and bone marrow transplantation 8. Pregnancy or lactation

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Beijing Friendship Hospital Beijing Beijing Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06771011 on ClinicalTrials.gov ↗ ← All trials in China