Prevalence and Prognosis of Drug-Induced Liver Injury
ConditionDrug-Induced Liver Injury
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University
About this trial
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:
1. Determine the hospital-based prevalence of DILI among adult patients attending Al-Rajhi Liver Hospital, Assiut University Hospitals. 2. Identify the most common medications, herbal preparations, and supplements causing liver injury. 3. Categorize the patterns of liver injury (hepatocellular, cholestatic, or mixed) using standardized biochemical calculations (R-ratio). 4. 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients aged 18 years or older.
Patients presenting to or admitted to Al-Rajhi Liver Hospital during the study period.
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
Disqualifiers
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
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
80 Participants
are grouped into 2 trial groupsGroup A: Retrospective DILI Cohort
Group B: Prospective DILI Cohort
Trial outcomes
Primary outcomes
1
Proportion of Patients With Unfavorable DILI Outcomes
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.
Time frame
Up to 1 yearLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: