Comparing two diagnostic methods for drug-induced liver injury
Prospective Comparative Validation Study of RUCAM and RECAM
This study is testing two different scoring systems to see which one better helps doctors diagnose drug-induced liver injury in hospitalized patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 407 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Beijing Friendship Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06771011 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with acute liver injury and a clear history of medication use.
Not a fit: Patients with chronic liver disease or those who do not have a clear medication history may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of diagnosing drug-induced liver injury, leading to better patient management.
How similar studies have performed: While there have been studies on DILI diagnostics, the comparative validation of RECAM and RUCAM in this specific context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing, Beijing Municipality
- Beijing Friendship Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Xinyan Zhao
- Email: zhao_xinyan@ccmu.edu.cn
- Phone: 13801001732
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.