NCT06771011 Prospective Comparative Validation Study of RUCAM and RECAM
| NCT ID | NCT06771011 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Friendship Hospital |
| Condition | Drug Induced Liver Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 407 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2026-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 407 participants in total. It began in 2023-05-01 with a primary completion date of 2026-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Xinyan Zhao
STUDY CHAIR
Beijing Friendship Hospital
Frequently Asked Questions
Who can join the NCT06771011 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Drug Induced Liver Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06771011 currently recruiting?
Yes, NCT06771011 is actively recruiting participants. Contact the research team at zhao_xinyan@ccmu.edu.cn for enrollment information.
Where is the NCT06771011 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06771011 clinical trial?
NCT06771011 is sponsored by Beijing Friendship Hospital. The principal investigator is Xinyan Zhao at Beijing Friendship Hospital. The trial plans to enroll 407 participants.