Multicenter quasi-experimental clinical trial to evaluate the efficacy of pharmacotherapeutic intervention on clinical outcomes in liver failure
- Conditions
- Drug-Related Side Effects and Adverse ReactionsVS3.002.001.001.010.001
- Registration Number
- RBR-9hyhm9c
- Lead Sponsor
- Centro de Ciências de Saúde - UFR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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