Comparing two diagnostic methods for drug-induced liver injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study involves 407 hospitalized patients with acute liver injury at Beijing Friendship Hospital. It aims to collect comprehensive clinical data, including demographic information, laboratory tests, imaging examinations, and liver biopsy pathology. The study will compare the diagnostic efficacy of two scoring systems, RECAM and RUCAM, in diagnosing drug-induced liver injury (DILI) and assess the consistency of these scores among different clinicians. Statistical analyses will be performed to evaluate the findings.

Why it matters

Who can join: the full rules

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

Where it's running

• Beijing Friendship Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Xinyan Zhao
• Email: zhao_xinyan@ccmu.edu.cn
• Phone: 13801001732

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Observational study on drug-induced liver injury in China

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• Registry for patients with drug-induced liver injury

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.