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

NCT ID: NCT04310501

Last Updated: 2021-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-23

Study Completion Date

2022-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Insufficiency, Chronic

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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)

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ioannina

OTHER

Sponsor Role lead

Responsible Party

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Evangelia Ntounousi

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Evangelia Ntounousi, PHD

Role: PRINCIPAL_INVESTIGATOR

University of Ioannina

Locations

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University Hospital of Ioannina

Ioannina, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Evangelia Ntounousi, PHD

Role: CONTACT

+302651099653

Facility Contacts

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Evangelia Dounousi, PHD

Role: primary

+302651099653

References

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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.

Reference Type BACKGROUND
PMID: 22752671 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21577077 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17986697 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17630042 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 11089838 (View on PubMed)

Other Identifiers

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RESCOMUOI82476

Identifier Type: -

Identifier Source: org_study_id

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