Hepatotoxicity by drugs

• Register: RPCEC
• Last refreshed on: 29 April 2024
• Main ID: RPCEC00000242
• Date of registration: 27/04/2017
• Prospective Registration: No
• Primary sponsor: Pharmaceutical Promotion and Prevention Group (P&PF)
• Public title: Hepatotoxicity by drugs
• Scientific title: Epidemiology and factors associated with drug hepatotoxicity in patients at IPS Universitaria Clínica León XIII
• Date of first enrolment: 04/11/2015
• Target sample size: Recruitment for a year since November 03, 2015
• Recruitment status: Complete
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000242-En
• Study type: Observational
• Study design: Allocation: N/A: single arm study. Masking: Open. Control group: Uncontrolled. Assignment: Single group. Purpose: Other
• Phase: N/A

Countries of recruitment

Colombia

Contacts

• Name: Alejandra Cano Paniagua
• Affiliation: Universidad de Antioquia

• Name: Alejandra Cano Paniagua
• Affiliation: Universidad de Antioquia

Key inclusion & exclusion criteria

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.

Age minimum: 18 years
Age maximum: None
Gender: Male/Female

Health Condition(s) or Problem(s) studied

Hepatotoxicity

Drug-Induced Liver Injury

Digestive System Diseases

Liver Diseases

Intervention(s)

No intervention apply
After the signed of informed consent, patient data is collected and analized. The Roussel Uclaf Causality Assessment Method (RUCAM) and Maria y Victorino (M&V) scales are applied to assess causality of the suspicious drug that cause hepatotoxicity.

Observational Study

Primary Outcome(s)

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.
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.
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.

Secondary Outcome(s)

1. Age (patient’ years). Measurement time: Between 6-48 hours at the patient admission.
2. Gender (Female, Male). Measurement time: Between 6-48 hours at the patient admission.
3. Selection and location of the patient (emergency service or hospitalization service in internal consultation). Measurement time: Between 6-24 hours at the patient admission.
4. Intake of alcohol (Beer: 200 mL (5.12 g), 300 mL (7.7 g), 330 (8.5 g). Wine: 100 mL (7.2 g), 200 mL (14.4 g). Glass of liquor: 45 mL (12.6 g). Criteria for alcoholism: more than 20 g/day in women and more than 40 g/day in men). Between 6-48 hours at the patient admission.
5. Ingestion of toxic substances (psychoactive substances). Measurement time: Between 6-48 hours at the patient admission.
6. Comorbidities (names). Measurement time: Between 6-48 hours at the patient admission.
7. Extra-hepatic signs and symptoms (names). Measurement time: Between 6-48 hours at the patient admission and, daily monitoring on the following hospital days.

Secondary ID(s)

IN11-2015

Source(s) of Monetary Support

University of Antioquia (UdeA) Institution of Health Services for the University of Antioquia (IPS Universitaria Leon XIII Clinic)

Secondary Sponsor(s)

University of Antioquia (UdeA)

Institution of Health Services for the University of Antioquia (IPS Universitaria Leon XIII Clinic)

Results

• Results available: Yes
• Date Posted: 15/08/2017
• Date Completed: 15/08/2017