Interactive E-health Database for the Identification of Potential Interactions Among Drugs Prescribed to CKD Patient

May 19, 2021 updated by: Evangelia Ntounousi, University of Ioannina

Development of an Interactive E-health Database Aimed to Identify Potential Interactions Among Drugs Prescribed to Chronic Kidney Disease (CKD) Patient

The aim of the current project is the development and implementation of an e-health database of drug interactions (drug-drug, drug-food, drug-alcohol and drug-herbal products interaction) to CKD patients in order to achieve a holistic approach to patient care and personalized medicine. The study will be conducted in the University of Ioannina (cooperation between the Department of Nephrology and the Laboratory of Physiology). Data will be collected form 150 CKD patients (Stages 1-5 pre-dialysis, undergoing dialysis, kidney transplantation). Sixty patients will be selected for the pilot study which will include blood and urine tests and specific polymorphism analysis (pharmacogenetic tests). Pilot implementation of the e-health database will be undertaken by health professionals of the Department of Nephrology (University Hospital of Ioannina) to test the system in realistic setting (usability, efficiency and efficacy) in order to make the necessary changes prior to full scale deployment.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
      • Ioánnina, Greece, 45110
        • Recruiting
        • University Hospital of Ioannina
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

150 patients with Chronic Kidney Disease (stages 1-5 pre-dialysis, kidney transplantation) from the Nephrology Department of University Hospital of Ioannina

Description

Inclusion Criteria:

  • Age>18 years
  • CKD diagnosis according to KDOQI Guidelines
  • absence of active malignancy
  • absence of decompensated heart failure New York Heart Association (NYHA) IV
  • absence of liver cirrhosis
  • patient's consent

Exclusion Criteria:

  • Age<18 years
  • active malignancy
  • decompensated heart failure NYHA IV
  • liver cirrhosis
  • patient's refusal to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
CKD Patients

Patients (n=150) with CKD (Stages 1-5 pre-dialysis, undergoing dialysis, kidney transplantation) who fulfil the inclusion criteria from the Nephrology Dept and Renal Transplant Unit of the University Hospital of Ioannina.

Sixty patients will be selected for the pilot study which will include blood and urine tests and specific polymorphism analysis (pharmacogenetic tests)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
E-health database
Time Frame: 1-12 months until completion of patients recruitment
E-health database of drug interactions (drug-drug, drug-food, drug-alcohol and drug-herbal products interaction) to CKD patients in order to achieve a holistic approach to patient care and personalized medicine.
1-12 months until completion of patients recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ioannina

Investigators

  • Principal Investigator: Evangelia Ntounousi, PHD, University of Ioannina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2020

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

March 9, 2020

First Submitted That Met QC Criteria

March 12, 2020

First Posted (Actual)

March 17, 2020

Study Record Updates

Last Update Posted (Actual)

May 20, 2021

Last Update Submitted That Met QC Criteria

May 19, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RESCOMUOI82476

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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