Hepatotoxicity by drugs

Not Applicable

• Conditions: Hepatotoxicity; Drug-Induced Liver Injury; Liver Diseases; Digestive System Diseases

• Registration Number: RPCEC00000242
• Lead Sponsor: Pharmaceutical Promotion and Prevention Group (P&PF)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-27
• Study Completion: 2017-08-15
• Results First Posted: 2019-04-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients older than 18 years.
2. Presumptive identification of hepatotoxicity: patients who, upon admission to the emergency room or during hospitalization, are assigned an increase in alanine aminotransferase values greater than 3 times and/or alkaline phosphatase higher than 2 times the upper limit of normal, and the physician in charge considers that the stay in the institution is superior to 48-72 hours, due to the need to follow the reduction or elevation of the altered values and confirm the possible hepatotoxicity.
3. Patients or caregivers who authorize their participation in the study through the signing of informed consent.

Exclusion Criteria

1. Patients with an increase in ALT values greater than 3 times the ULN and / or ALP higher than 2 times the ULN for more than 6 months.
2. Patients with acute coronary syndrome.
3. Patients with terminal disease.
4. Patients with some type of neoplasm under treatment.
5. Patients with intoxications
6. Patients with alcohol consumption greater than 20 g / day in women and greater than 40 g/day in men.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Alteration of liver tests as indicator of hepatic injury (Increase of alanine aminotransferase>3 times and/or increase of alkaline phosphatase>2 times the upper limit of normal. Normal ranges for alanine aminotransferase: 10-49 U/L and alkaline phosphatase: 45-129 U/L). Measurement time: at the patient admission, monitoring between 48-72 hours during hospitalization.<br>2. Used drugs (identification of the active principle, concentration, trade name, dose interval, administration route). Measurement time: data collection between 6-48 hours at the patient admission and, daily monitoring on the following hospital days.<br>3. Use of natural products and dietary supplements (identification of the active principle, concentration, trade name, dose interval, way of administration). Measurement time: data collection between 6-48 hours at the patient admission and, daily monitored on the following hospital days.