Prospective Comparative Validation Study of RUCAM and RECAM

NCT06771011 | Recruiting

• 1 other identifier: MR-11-23-024371
• Study Type: observational
• Target: 407
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Induced Liver Injury

Outcome Measures

Primary Outcomes (2)

• RECAM is not inferior to RUCAM

  Area under the curve (AUC) values for the identification of DILI cases were compared by the Delong method. The AUROC of RUCAM in diagnosing DILI was higher than RECAM. The pattern of liver injury was classified by the R-value based on the first available liver chemistries. Individual scores of the RUCAM and RECAM were calculated with the appropriate algorithms.

  July 2025

• RECAM is inferior to RUCAM

  Area under the curve (AUC) values for the identification of DILI cases were compared by the Delong method. The AUROC of RUCAM in diagnosing DILI was higher than RECAM. The pattern of liver injury was classified by the R-value based on the first available liver chemistries. Individual scores of the RUCAM and RECAM were calculated with the appropriate algorithms.

  July 2025

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population who met the above inclusion and exclusion criteria

You may qualify if:

• Older than 18 years old
• 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
• 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
• All the key data for RUCAM and RECAM can accurately be contained.
• 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

You may not qualify if:

• 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
• 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
• 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
• The cause of the patient's acute liver injury could not be determined
• Acetaminophen liver injury
• Toxic liver disease, such as mushroom poisoning caused liver damage, chemical poisons (such as paint, etc.) liver damage
• Previous liver transplantation and bone marrow transplantation
• Pregnancy or lactation

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

Chemical and Drug Induced Liver Injury

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Poisoning

Study Officials

• Xinyan Zhao

  Beijing Friendship Hospital

  STUDY CHAIR

Central Study Contacts

Xinyan Zhao

CONTACT

13801001732; zhao_xinyan@ccmu.edu.cn

Yao Meng

CONTACT

13011670736; mengyao2954@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: January 13, 2025
• Study Start: May 1, 2023
• Primary Completion: February 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 13, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)