Individual Risk Profiles for Adverse Drug Reactions in Geriatric Patients

NCT ID: NCT05247814

Last Updated: 2022-06-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-31
• Study Completion Date: 2032-02-29

Brief Summary

This project will generate a prospective cohort of geriatric patients with polypharmacy which will be characterized for vulnerability profiles of adverse drug reactions.

Detailed Description

Adverse drug reactions are common in older patients and can lead to severe outcomes such as falls, hospitalizations and death. They are dose-dependent and may for example be caused by inappropriate dosing due to a reduced kidney function. Also, the use of potentially inappropriate medications in older patients can result in a negative benefit-/ risk-ratio. Additionally, drug metabolism in older patients is altered due to a variety of reasons and pharmacogenetic variants of drug metabolizing enzymes can lead to a more than 10-fold interinidividual variation of drug clearance. The risk of the individual patient to experience an adverse drug reactions is determined by many reasons. Therefore, this study aims to identify patient risk profiles with regard to pharmacogenetics, drug interactions, impaired functional and cognitive status and individual drug metabolism.

Participants for this study will be consecutively recruited from patients admitted to the Interdisciplinary Polypharmacy Consultation Service of the Department of Geriatric's University Outpatient Clinic in cooperation with the Institute of Clinical Pharmacology. Regardless of their participation in this study, patients in the outpatient clinic will perform several tests and questionnaires following the comprehensive geriatric assessment. The purpose of the cohort study is to document and evaluate routine health data collected in the outpatient clinic for polypharmacy in geriatric patients (laboratory tests as well as a comprehensive medication history with therapy recommendations issued by a subsequent pharmaceutical council for both the patients and the primary care physicians).

Procedures conducted specifically for this study are a long-term capture and detailed history of all suspected adverse drug reactions, examining the fear of falling (FES-I questionnaire) and blood sampling for exploratory pharmacogenomic analyses (on cohort level, not patient diagnostics).

Aim of the long-term cohort of geriatric patients with polypharmacy is to identify risk profiles for adverse drug reactions that are specific for the population of older individuals.

Conditions

Polypharmacy; Pharmacogenetics; Pharmacogenomic Testing; Drug-Related Side Effects and Adverse Reactions

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients admitted to interdisciplinary polypharmacy consultation service

Patients admitted to the Interdisciplinary Polypharmacy Consultation Service of the Department of Geriatric's University Outpatient Clinic in cooperation with the Institute of Clinical Pharmacology

Pharmacogenomic testing of a panel of important pharmacogenes to detect genetic variants and evaluate the association between genetically predicted and measured drug metabolism

Intervention Type: GENETIC

All planned interventions are explorative analyses of biological and genetic risk profiles that can contribute to patients' individual risk for adverse drug reactions, i.e. due to variability in drug metabolism

Adverse Drug Reaction detection

Intervention Type: OTHER

During appointments in the university outpatient clinic, patients will undergo a comprehensive adverse drug reaction (ADR) assessment based on an ADR diary they were handed at enrolment

Falls Efficacy Scale International (FES-I)

Intervention Type: OTHER

The FES-I wil be obtained to estimate fear of falling

Interventions

Pharmacogenomic testing of a panel of important pharmacogenes to detect genetic variants and evaluate the association between genetically predicted and measured drug metabolism

All planned interventions are explorative analyses of biological and genetic risk profiles that can contribute to patients' individual risk for adverse drug reactions, i.e. due to variability in drug metabolism

Intervention Type: GENETIC

Adverse Drug Reaction detection

During appointments in the university outpatient clinic, patients will undergo a comprehensive adverse drug reaction (ADR) assessment based on an ADR diary they were handed at enrolment

Intervention Type: OTHER

Falls Efficacy Scale International (FES-I)

The FES-I wil be obtained to estimate fear of falling

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 70 years or older
• Current drug therapy with three or more drugs
• Being a patient in the interdisciplinary polypharmacy consultation service of the geriatric university outpatient clinic
• Sufficient mobility (minimum: Wheelchair mobility)
• Written informed consent of the patient or the legal representative

Exclusion Criteria

• No sufficient communication possible
• Patients classified as terminally ill by the medical staff
• Patients, that are incapable to give their informed consent and who do not have a legal representative

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

B. Braun Foundation

OTHER

Sponsor Role: collaborator

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Julia Stingl

Univ.-Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julia C. Stingl, MD, ScD

Role: PRINCIPAL_INVESTIGATOR

Institute of Clinical Pharmacology, University Hospital RWTH Aachen

Central Contacts

Mathias Freitag

Role: CONTACT

mfreitag@ukaachen.de

+492417501116 ext. +492418089134

Julia C. Stingl, MD, ScD

Role: CONTACT

jstingl@ukaachen.de

+492418089130

Other Identifiers

21-216

Identifier Type: -

Identifier Source: org_study_id