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NCT Number: NCT05140590

Interactions Between Antihypertensive Drugs and Drugs Prescribed in the Emergency Room

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.

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Key information

Conditions

Drug Interactions Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto Méxicano del Seguro Social HGZ No.51

Gómez Palacio, Durango, 35025, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of theoretical IFFs detected

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Control of hypertension according to blood pressure figures at admission

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Instituto Mexicano del Seguro Social

Other Gov

Registry information

Official study title

Pharmacological Interactions Between Antihypertensive Regimens and Drugs Prescribed in the Emergency Department of the HGZ 51

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Dec 1, 2021
Registry last updated
Mar 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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