Interactions Between Antihypertensive Drugs and Drugs Prescribed in the Emergency Room

NCT ID: NCT05140590

Last Updated: 2022-03-29

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

COMPLETED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-02-28

Brief Summary

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Drug interactions (IFF) are events that occur when multiple drugs are administered at the same time to an individual. People with arterial hypertension generally require therapeutic regimens based on 2 or more drugs for their adequate control, which makes them patients with polypharmacy. When these patients require urgent medical attention, there is a risk that IFFs will occur between their base treatment and the drugs that are prescribed to solve the added condition.

Objective. To determine the frequency of pharmacological interactions between antihypertensive regimens and drugs used in the emergency service of Hospital General de Zona No 51 (HGZ 51).

Material and methods: Observational, descriptive, and prospective study. The participants will be eligible patients with systemic arterial hypertension treated in the emergency room of HGZ 51 in Gómez Palacio, Durango. Support systems will be used for clinical decision, to identify potential IFFs and to be able to classify them according to their mechanism (pharmacokinetics and pharmacodynamics) and severity. A descriptive statistical analysis will be carried out in the SPSS program using measures of frequency, dispersion and central tendency.

Detailed Description

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The researchers will invite individuals with high blood pressure who come to the emergency department in the period from January 2021 to December 2021 to participate in the study. They will be questioned about the selection criteria, and if they are eligible to be included in the study, they will be provided with the informed consent letter for reading, clarification of doubts and signature. Each participant will receive a copy of the informed consent letter.

Participants will be questioned directly to obtain information about their general data, medical history and about their drug treatment for hypertension. The rest of the data (admission diagnosis, drugs administered during their hospital stay, etc.) will be obtained from the clinical record, as well as the blood pressure measurements on admission, during their hospital stay and upon discharge. The analysis of the theoretical pharmacological interactions and their classification will be carried out prior to feeding the database using the IBM Micromedex Drug Interactions and iDoctus Clinical Decision Support Systems (CDSS).

The information obtained will be emptied into an Excel database for subsequent statistical analysis with the SPSS 21 program. The study information will remain confidential under the responsibility of the responsible researcher. As a protection measure on the information collected for the investigation, the personal identification data will be substituted by folio numbers.

Conditions

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Drug Interactions Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with a diagnosis of hypertension admitted to the emergency department

Direct questioning about general data, medical history and about the pharmacological scheme for the treatment of hypertension.

Review of clinical records to obtain data about the admission diagnosis, drugs administered during their hospital stay, and blood pressure figures at admission, during hospital stay and at discharge.

Analysis and classification of theoretical drug interactions using the IBM Micromedex Drug Interactions and iDoctus clinical decision support systems.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of arterial hypertension confirmed that they are hospitalized in the emergency department of HGZ 51.
* Pharmacological treatment already established to control hypertension.
* Accept to participate and sign the informed consent.
* Prescription and / or administration of additional drugs to your antihypertensive treatment during your hospital stay in the emergency department.

Exclusion Criteria

* That they do not know or do not provide complete information on their basic antihypertensive treatment.

Elimination criteria

* Survey with incomplete pharmacotherapeutic history data.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Mexicano del Seguro Social

OTHER_GOV

Sponsor Role lead

Responsible Party

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Lilia Edith Luque Esparza

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lilia E Luque-Esparza, Dra.

Role: PRINCIPAL_INVESTIGATOR

IMSS

Locations

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Instituto Méxicano del Seguro Social HGZ No.51

Gómez Palacio, Durango, Mexico

Site Status

Countries

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Mexico

References

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Amariles P, Giraldo NA, Faus MJ. [Clinical relevance of drug interactions]. Med Clin (Barc). 2007 Jun 2;129(1):27-35. doi: 10.1157/13106681. Spanish.

Reference Type BACKGROUND
PMID: 17570184 (View on PubMed)

Iniesta-Navalon C, Urbieta-Sanz E, Gascon-Canovas JJ. [Analysis of the drug interactions associated to domiciliary drug therapy in elderly hospitalized patients]. Rev Clin Esp. 2011 Jul-Aug;211(7):344-51. doi: 10.1016/j.rce.2011.04.005. Epub 2011 Jun 2. Spanish.

Reference Type BACKGROUND
PMID: 21640341 (View on PubMed)

Horn JR, Hansten PD, Chan LN. Proposal for a new tool to evaluate drug interaction cases. Ann Pharmacother. 2007 Apr;41(4):674-80. doi: 10.1345/aph.1H423. Epub 2007 Mar 27.

Reference Type BACKGROUND
PMID: 17389673 (View on PubMed)

Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; ESC Scientific Document Group. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J. 2018 Sep 1;39(33):3021-3104. doi: 10.1093/eurheartj/ehy339. No abstract available.

Reference Type BACKGROUND
PMID: 30165516 (View on PubMed)

Morales-Olivas FJ, Estan L. [Antihypertensive drug-drug interactions]. Med Clin (Barc). 2005 May 28;124(20):782-9. doi: 10.1157/13075851. Spanish.

Reference Type BACKGROUND
PMID: 15927106 (View on PubMed)

Related Links

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http://www.imss.gob.mx/sites/all/statics/guiasclinicas/688GER.pdf

Guía de práctica clínica de interacciones farmacológicas potenciales en la atención del adulto mayor

http://ve.scielo.org/scielo.php?script=sci_arttext&pid=S0798-02642016000100001&lng=es.

Drug Interactions in hospitalized patients in the Internal Medicine Hospital University " Dr. Angel Larralde ". June 2014 - December 2015

http://www.imss.gob.mx/sites/all/statics/guiasclinicas/558GER.pdf

Guía de Práctica Clínica Prescripción farmacológica razonada para el adulto mayor

Other Identifiers

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R-2020-902-030

Identifier Type: -

Identifier Source: org_study_id

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