Prevalence and Prognosis of Drug-Induced Liver Injury at Al-Rajhi Liver Hospital
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Proportion of Patients With Unfavorable DILI Outcomes
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18 years or older.
- •Patients presenting to or admitted to Al-Rajhi Liver Hospital during the study period.
- •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.
- •Documented exposure to a suspected medication, herbal preparation, or dietary supplement preceding the onset of liver injury, with a compatible temporal relationship.
- •For the retrospective cohort: availability of adequate medical records to establish the diagnosis of DILI and assess clinical outcomes.
- •For the prospective cohort: provision of informed consent for study participation and follow-up (by the patient or a legally authorized representative).
排除标准
- •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
研究组 & 干预措施
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.
结局指标
主要结局
Proportion of Patients With Unfavorable DILI Outcomes
时间窗: Up to 1 year
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.
次要结局
未报告次要终点
研究者
Mina Salama Tawfik Yousef
Resident of Internal Medicine
Assiut University