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

NCT04310501 | Unknown

• 1 other identifier: RESCOMUOI82476
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Insufficiency, Chronic

Keywords

Drug Interactions; Polymorphism, Genetic; Pharmacogenetics; Databases, Pharmaceutical

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Ioannina: lead

Study Sites (1)

University Hospital of Ioannina

Ioannina, 45110, Greece

RECRUITING

Related Publications (5)

• 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.

  PMID: 22752671 BACKGROUND

• 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.

  PMID: 21577077 BACKGROUND

• 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.

  PMID: 17986697 BACKGROUND

• 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.

  PMID: 17630042 BACKGROUND

• Meyer UA. Pharmacogenetics and adverse drug reactions. Lancet. 2000 Nov 11;356(9242):1667-71. doi: 10.1016/S0140-6736(00)03167-6.

  PMID: 11089838 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Evangelia Ntounousi, PHD

  University of Ioannina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evangelia Ntounousi, PHD

CONTACT

+302651099653; evangeldou@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 17, 2020
• Study Start: April 23, 2020
• Primary Completion: September 1, 2021
• Study Completion: March 1, 2022
• Last Updated: May 20, 2021

Record last verified: 2021-05

Locations

GR (1)