Clinical trial NCT04310501: Interactive E-health Database for the Identification of Potential Interactions Among Drugs Prescribed to CKD Patient
Official title: Development of an Interactive E-health Database Aimed to Identify Potential Interactions Among Drugs Prescribed to Chronic Kidney Disease (CKD) Patient
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Renal Insufficiency, Chronic
Keywords: Drug Interactions
Polymorphism, Genetic
Pharmacogenetics
Databases, Pharmaceutical
Lead sponsor: University of Ioannina
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: E-health database
timeFrame: 1-12 months until completion of patients recruitment
Secondary outcomes:
Other outcomes:
Locations:
city: Ioánnina
country: Greece
facility: University Hospital of Ioannina
Study officials:
affiliation: University of Ioannina
name: Evangelia Ntounousi, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andersson ML, Bottiger 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.
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.
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. doi: 10.1001/jama.298.17.2038.
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.
citation: Meyer UA. Pharmacogenetics and adverse drug reactions. Lancet. 2000 Nov 11;356(9242):1667-71. doi: 10.1016/S0140-6736(00)03167-6.