NCT04302506

Correlative Cohort Study on the Clinical Features and Prognosis of Drug-induced Liver Injury

The Correlative Cohort Study on the Clinical Features and Prognosis of Drug-induced Liver Injury

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Beijing Ditan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This was a retrospective study of a clinical observational cohort. The patients were admitted and definitely diagnosed by liver biopsy as drug-induced liver injury from September 2014 to September 2019, in the Second Department of Liver Disease, Beijing Ditan Hospital Affiliated to Capital Medical University were enrolled, and these patients also met the RUCAM score and were clinically diagnosed as DILI. Baseline clinical data and follow-up biochemical data at 3, 6, and 12 months were collected. SPSS software was used to analyze the characteristics of clinical data and the dynamic changes of biochemical indicators. Logistic regression was used to analyze the risk factors associated with the chronicity of DILI. Bivariate Logistic regression model and ROC curve were used to obtain the clinical indicators for combined diagnosis of chronicity of DILI patients. To investigate the clinical features and prognostic factors of drug-induced liver injury.

Detailed description

This was a retrospective study of a clinical observational cohort. The patients were admitted and definitely diagnosed by liver biopsy as drug-induced liver injury from September 2014 to September 2019, in the Second Department of Liver Disease, Beijing Ditan Hospital Affiliated to Capital Medical University were enrolled, and these patients also met the RUCAM score and were clinically diagnosed as DILI. Baseline clinical data and follow-up biochemical data at 3, 6, and 12 months were collected. SPSS software was used to analyze the characteristics of clinical data and the dynamic changes of biochemical indicators. Logistic regression was used to analyze the risk factors associated with the chronicity of DILI. Bivariate Logistic regression model and ROC curve were used to obtain the clinical indicators for combined diagnosis of chronicity of DILI patients. To investigate the clinical features and prognostic factors of drug-induced liver injury.

Conditions

• Drug-induced Liver Injury

Timeline

• Start date: 2020-04-01
• Primary completion: 2021-04-30
• Completion: 2021-04-30
• First posted: 2020-03-10
• Last updated: 2020-03-10

Locations

1 site across 1 country: China