Interactions Between Antihypertensive Drugs and Drugs Prescribed in the Emergency Room

Sponsor
Instituto Mexicano del Seguro Social (Other)
Overall Status
Completed
CT.gov ID
NCT05140590
Collaborator
(none)
53
1
13.9
3.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    53 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Pharmacological Interactions Between Antihypertensive Regimens and Drugs Prescribed in the Emergency Department of the HGZ 51
    Actual Study Start Date :
    Jan 1, 2021
    Actual Primary Completion Date :
    Dec 31, 2021
    Actual Study Completion Date :
    Feb 28, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Number of theoretical IFFs detected [Duration of hospitalization (15 days)]

      Potential for the prescription of a drug associated with other active ingredients to generate a risk of drug interaction. Number of theoretical IFFs detected by support systems for clinical decision

    2. Frequency of IFF by pharmacological mechanism [Duration of hospitalization (15 days)]

      Number of interactions detected by support systems for clinical decision classified according to the pharmacological mechanism into pharmacokinetics or pharmacodynamics. The interactions of absorption, distribution, metabolism and excretion will be considered pharmacokinetic. Interactions by synergy (addition, potentiation), antagonism, hypersensitization and desensitization will be considered pharmacodynamic.

    3. Degree severity of drug interaction detected [Duration of hospitalization (15 days)]

      Classification of IFFs according to the theoretical severity provided by the support systems for clinical decision. Minors (without clinical condition) Moderate (may cause deterioration of clinical status) Major (can be life-threatening or cause permanent damage) Contraindicated (should not be used simultaneously)

    Secondary Outcome Measures

    1. Control of hypertension according to blood pressure figures at admission [upon admission (2 horas)]

      According to the provisions of the 2018 ESC/ESH Guide on the diagnosis and treatment of arterial hypertension, blood pressure figures are considered to be control at admission to the emergency room of: Systolic blood pressure (SBP) <140 mmHg Diastolic blood pressure (DBP) <90 mmHg

    2. Control of hypertension according to blood pressure figures during hospitalization [Duration of hospitalization (15 days)]

      According to the provisions of the 2018 ESC/ESH Guide on the diagnosis and treatment of arterial hypertension, blood pressure figures are considered to be control during hospitalization to the emergency room of: SBP <140 mmHg DBP <90 mmHg

    3. Control of hypertension according to blood pressure figures at discharge [At the time of discharge (2-15 days)]

      In accordance with the provisions of the 2018 ESC/ESH Guide on the diagnosis and treatment of arterial hypertension, blood pressure figures are considered controlled upon discharge from hospitalization in the emergency department of: SBP <140 mmHg DBP <90 mmHg

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Instituto Méxicano del Seguro Social HGZ No.51 Gomez Palacio Durango Mexico 35025

    Sponsors and Collaborators

    • Instituto Mexicano del Seguro Social

    Investigators

    • Principal Investigator: Lilia E Luque-Esparza, Dra., IMSS

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Lilia Edith Luque Esparza, Principal Investigator, Instituto Mexicano del Seguro Social
    ClinicalTrials.gov Identifier:
    NCT05140590
    Other Study ID Numbers:
    • R-2020-902-030
    First Posted:
    Dec 1, 2021
    Last Update Posted:
    Mar 29, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Lilia Edith Luque Esparza, Principal Investigator, Instituto Mexicano del Seguro Social
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 29, 2022