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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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.
Beskrivelse
Inclusion Criteria:
-
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.
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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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: OTHER
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of Patients With Unfavorable DILI Outcomes
Tidsramme: 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. |
Up to 1 year
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DILI: Prevalence & Prognosis
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