Drug-Related Side Effects and Adverse Reactions
Conditions
Interventions
Pre-post-implementation quasi-experimental multicenter trial in hospitalized patients with Child-Pugh classes B and C chronic liver disease, comparing a pharmaceutical intervention to the standard of
V03.175.250
Sponsors
Centro de Ciências de Saúde - UFRN
Hospital Universitário Onofre Lopes
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age over 18 years; both sexes; hospitalized at Onofre Lopes University Hospital for chronic liver disease as the main diagnosis or as a comorbidity; clinical and laboratory signs of moderate or severe liver failure defined by Child-Pugh class B or C; signing of the Free and Informed Consent Form
Exclusion criteria
Exclusion criteria: Hospitalization for adverse reaction; discharge from hospital less than 3 months ago; hospitalization only for diagnostic procedure (e.g. liver biopsy) or procedure (e.g. esophageal variceal binding); patients transferred from another hospital or department; patients previously included in this study; diagnosis of metastatic liver, hepatocellular carcinoma, cholangiocarcinoma, sclerosing cholangitis, primary biliary cholangitis, hemochromatosis, Wilson's disease, zoonoses (echinococcosis, amebiasis, schistosomiasis, fasciolosis); acute hepatitis of viral, alcoholic, autoimmune, toxic, or gestational etiology
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This project will produce new information on relevant aspects of the treatment of patients with moderate or severe hepatic impairment, mainly those related to patient safety, but also related to the clinical evolution and medical treatment during hospitalizations. In particular, the following information will be obtained: Efficacy of a pharmacotherapeutic intervention in reducing unfavorable outcomes, drug-related problems (PRMs) and adverse drug reactions (ADRs); Incidence of PRMs and distribution by causes according to the Pharmaceutical Care Network Europe (PCNE) v9.1 classification | — |
Secondary
| Measure | Time frame |
|---|---|
| The study is expected to characterize the notifications to the prescriber, acceptance rate of the recommendations, and outcomes of the interventions as well as the prescribed drugs, indications and potential drug interactions. In addition the incidence of adverse drug reactions (ADRs) and characterization, description of the causative drugs, distribution by mode of detection of ADR, distribution by category of damage, distribution by severity and by preventability. In addition to what has been described, the study is still able to perform the agreement of the Naranjo and Liverpool algorithms in the attribution of causality, as well as the sensitivity, specificity and positive and negative predictive values of the Medication Module of the IHI Global Triggers Tool instrument for the identification of ADRs | — |
Countries
Brazil
Contacts
Public ContactNara Macedo
Centro de Ciências de Saúde - UFRN
Outcome results
None listed