Prevalence and Prognosis of Drug-Induced Liver Injury
Prevalence and Prognosis of Drug-Induced Liver Injury at Al-Rajhi Liver Hospital
Drug-induced liver injury (DILI) is an important cause of acute liver damage that occurs when prescription medications, over-the-counter drugs, herbal products, or dietary supplements harm the liver. DILI can range from mild abnormalities in liver enzymes that cause no symptoms to severe conditions such as acute liver failure, the need for an urgent liver transplant, or death. Diagnosing DILI is often challenging because it shares symptoms with many other liver diseases, and there are currently no single specific blood tests to confirm it.
There is limited data regarding the prevalence, causative agents, and clinical outcomes of DILI among patients in Upper Egypt.
The main purpose of this study is to:
- Determine the hospital-based prevalence of DILI among adult patients attending Al-Rajhi Liver Hospital, Assiut University Hospitals.
- Identify the most common medications, herbal preparations, and supplements causing liver injury.
- Categorize the patterns of liver injury (hepatocellular, cholestatic, or mixed) using standardized biochemical calculations (R-ratio).
- Evaluate patient outcomes and identify clinical and laboratory factors that predict unfavorable outcomes, such as acute liver failure, liver transplantation, or death.
The study is an observational study conducted over a two-year period using two approaches:
- A retrospective chart review of adult patients diagnosed with DILI during the first year.
- A prospective follow-up of consecutive adult patients who present with DILI during the second year.
Participants will receive standard medical care as directed by their treating physicians. Routine medical data, laboratory tests, imaging results, and treatment details will be recorded and analyzed to help improve the early detection, prevention, and management of DILI in clinical practice.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Adult patients (aged 18 years or older) presenting to or admitted to Al-Rajhi Liver Hospital, Assiut University Hospitals, Assiut, Egypt, who fulfill the predefined clinical and biochemical criteria for drug-induced liver injury (DILI) following exposure to a suspected prescription drug, herbal preparation, or dietary supplement.
Descripción
Inclusion Criteria:
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Adult patients aged 18 years or older.
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Patients presenting to or admitted to Al-Rajhi Liver Hospital during the study period.
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Patients fulfilling the predefined biochemical and clinical criteria for drug-induced liver injury (DILI):
- Alanine aminotransferase (ALT) >= 5 times the upper limit of normal (ULN); or
- Alkaline phosphatase (ALP) >= 2 times the ULN (particularly when accompanied by elevated gamma-glutamyl transferase [GGT] and in the absence of a known bone source); or
- ALT >= 3 times the ULN with simultaneous total bilirubin > 2 times the ULN.
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Documented exposure to a suspected medication, herbal preparation, or dietary supplement preceding the onset of liver injury, with a compatible temporal relationship.
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For the retrospective cohort: availability of adequate medical records to establish the diagnosis of DILI and assess clinical outcomes.
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For the prospective cohort: provision of informed consent for study participation and follow-up (by the patient or a legally authorized representative).
Exclusion Criteria:
- Patients younger than 18 years
- Patients in whom an alternative etiology of acute liver injury is clearly established (e.g., acute viral hepatitis, autoimmune hepatitis, biliary obstruction, ischemic/hypoxic hepatitis) and DILI is considered unlikely
- Patients with insufficient clinical or laboratory data to verify whether diagnostic criteria for DILI are fulfilled
- Patients in the retrospective cohort with inadequate outcome records where assessment of the primary clinical endpoint is not possible
- Patients (or their legal representatives) who decline participation in the prospective cohort
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: OTHER
Número de grupos/cohortes
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
|---|
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Retrospective DILI Cohort
Eligible adult patients (aged 18 years or older) evaluated at Al-Rajhi Liver Hospital during the first year of the study period who fulfill the predefined clinical and biochemical criteria for drug-induced liver injury (DILI), identified via medical record review. |
|
Prospective DILI Cohort
Consecutive eligible adult patients (aged 18 years or older) presenting to or admitted to Al-Rajhi Liver Hospital during the second year of the study period who fulfill the predefined clinical and biochemical criteria for drug-induced liver injury (DILI) and are followed prospectively. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of Patients With Unfavorable DILI Outcomes
Periodo de tiempo: Up to 1 year
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Proportion of patients with drug-induced liver injury who develop a composite unfavorable outcome, defined as acute liver failure (acute liver injury with hepatic coagulopathy and clinically apparent hepatic encephalopathy without pre-existing severe chronic liver disease), liver transplantation, or death attributable to severe DILI. |
Up to 1 year
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Enfermedades del HIGADO
- Trastornos inducidos químicamente
- Efectos secundarios y reacciones adversas relacionados con los medicamentos
- Envenenamiento
- Insuficiencia hepática
- Insuficiencia hepática
- Insuficiencia Hepática, Aguda
- Daño hepático inducido por sustancias químicas y fármacos
Otros números de identificación del estudio
Otros números de identificación del estudio
- DILI: Prevalence & Prognosis
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