Drug-induced Liver injury. Sequelae of poisoning by drugs, medicaments and biological substances
Conditions
Interventions
Intervention 1: Control group: The patients of this group will be treated with N-acetylcysteine (NAC) at a dose of 300mg/kg/day divided every 8 hours. This treatment will start when the patient is hos
Sponsors
Karaj University of Medical Sciences
Eligibility
Sex/Gender
All
Age
12 Years to 80 Years
Inclusion criteria
Inclusion criteria: All women and men between the ages of 12 and 80 who have laboratory complications of Liver damage caused by Drug poisoning in the form of an increase in Liver enzymes AST, ALT more than 5 times the upper limit of normal, regardless of the presence of clinical symptoms, will be included in the study. All women and men between the ages of 12 and 80 who have laboratory complications of Liver damage caused by drug poisoning in the form of an increase in AST, ALT, and ALKP to twice the upper limit of normal along with total Bilirubin above 2 mg/dl will be included in the study. All women and men between the ages of 12 and 80 who have laboratory complications of Liver damage caused by drug poisoning in the form of an increase in AST, ALT to three times the upper limit of normal despite clinical symptoms (such as loss of appetite, fatigue, weakness and lethargy, nausea and vomiting, abdominal pain preferably epigastric and RUQ, itching, yellow skin or sclera, colorless stool or dark urine) will be included in the study. Since Liver damage caused by drug poisoning may not necessarily have significant and clear clinical symptoms, the preferred entry criterion will be the elevation of Liver enzymes, which will determine the importance of clinical symptoms in decision making.
Exclusion criteria
Exclusion criteria: Patients with a history of underlying diseases of the Liver and Bile ducts (such as Alcoholic hepatitis, Autoimmune hepatitis, Non-alcoholic fatty liver disease (NAFLD), Viral hepatitis including Hepatitis B virus or Hepatitis C virus).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum levels of Aspartate aminotransferase(AST). Timepoint: At the beginning of hospitalization and then daily until discharge from the hospital. Method of measurement: Lab test results in the patient's hospital file.;Serum levels of Alanine aminotransferase(ALT). Timepoint: At the beginning of hospitalization and then daily until discharge from the hospital. Method of measurement: Lab test results in the patient's hospital file.;Serum levels of Alkaline phosphatase(ALP). Timepoint: At the beginning of hospitalization and then daily until discharge from the hospital. Method of measurement: Lab test results in the patient's hospital file.;Serum levels of Total Bilirubin. Timepoint: At the beginning of hospitalization and then daily until discharge from the hospital. Method of measurement: Lab test results in the patient's hospital file.;Serum levels of Direct Bilirubin. Timepoint: At the beginning of hospitalization and then daily until discharge from the hospital. Method of measurement: Lab test results in the patient's hospital file. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical symptoms caused by hepatotoxicity (Loss of appetite, fatigue, weakness and lethargy, nausea and vomiting, abdominal pain preferably in the Epigastrium and RUQ, itching, yellowing of the skin or sclera, colorless stool or dark urine). Timepoint: At the beginning of hospitalization and then during daily visits of patient until discharge from the hospital. Method of measurement: By taking a history from the patient and asking the patient about the mentioned symptoms and during clinical examinations on daily visits. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAva Doosti
Karaj University of Medical Sciences
Outcome results
None listed