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

Renal Insufficiency, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04310501
• Other study ID #: RESCOMUOI82476
• Status: Recruiting
• Start date: April 23, 2020
• Est. completion date: March 2022

Study information

• Verified date: May 2021
• Source: University of Ioannina
• Contact: Evangelia Ntounousi, PHD
• Phone: +302651099653
• Email: evangeldou[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 2022
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Renal Insufficiency
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Greece	University Hospital of Ioannina	Ioánnina

Sponsors (1)

Lead Sponsor	Collaborator
University of Ioannina

Country where clinical trial is conducted

Greece, 

References & Publications (5)

Andersson ML, Böttiger Y, Lindh JD, Wettermark B, Eiermann B. Impact of the drug-drug interaction database SFINX on prevalence of potentially serious drug-drug interactions in primary health care. Eur J Clin Pharmacol. 2013 Mar;69(3):565-71. doi: 10.1007/s00228-012-1338-y. Epub 2012 Jul 1. — View Citation

Classen DC, Phansalkar S, Bates DW. Critical drug-drug interactions for use in electronic health records systems with computerized physician order entry: review of leading approaches. J Patient Saf. 2011 Jun;7(2):61-5. doi: 10.1097/PTS.0b013e31821d6f6e. Review. — View Citation

Coresh J, Selvin E, Stevens LA, Manzi J, Kusek JW, Eggers P, Van Lente F, Levey AS. Prevalence of chronic kidney disease in the United States. JAMA. 2007 Nov 7;298(17):2038-47. — View Citation

Mallet L, Spinewine A, Huang A. The challenge of managing drug interactions in elderly people. Lancet. 2007 Jul 14;370(9582):185-191. doi: 10.1016/S0140-6736(07)61092-7. Review. — View Citation

Meyer UA. Pharmacogenetics and adverse drug reactions. Lancet. 2000 Nov 11;356(9242):1667-71. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	E-health database	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