Prevalence and Prognosis of Drug-Induced Liver Injury

NCT07830901 | Not Yet Recruiting

• 1 other identifier: DILI: Prevalence & Prognosis
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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:

• 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.

Conditions

Drug-Induced Liver Injury

Keywords

DILI; Hepatotoxicity; RUCAM; Acute Liver Failure; Drug-Induced Liver Injury Pattern

Outcome Measures

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.

  Up to 1 year

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Chemical and Drug Induced Liver Injury; Liver Failure, Acute

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Internal Medicine

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 21, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 21, 2026

Record last verified: 2026-09