Interactions Between Antihypertensive Drugs and Drugs Prescribed in the Emergency Room

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Drug Interactions

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 Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• Mexico
  • Durango
    • Gomez Palacio, Durango, Mexico, 35025
      • Instituto Méxicano del Seguro Social HGZ No.51

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Beneficiaries with a history of a diagnosis of arterial hypertension who are hospitalized in the emergency service of the HGZ 51.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of theoretical IFFs detected	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	Duration of hospitalization (15 days)
Frequency of IFF by pharmacological mechanism	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.	Duration of hospitalization (15 days)
Degree severity of drug interaction detected	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)	Duration of hospitalization (15 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Control of hypertension according to blood pressure figures at admission	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	upon admission (2 horas)
Control of hypertension according to blood pressure figures during hospitalization	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	Duration of hospitalization (15 days)
Control of hypertension according to blood pressure figures at discharge	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	At the time of discharge (2-15 days)

Collaborators and Investigators

• Sponsor: Instituto Mexicano del Seguro Social
• Investigators: Principal Investigator: Lilia E Luque-Esparza, Dra., IMSS

Publications and helpful links

General Publications

• 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. Erratum In: Eur Heart J. 2019 Feb 1;40(5):475.
• 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.
• 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.
• 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.
• Morales-Olivas FJ, Estan L. [Antihypertensive drug-drug interactions]. Med Clin (Barc). 2005 May 28;124(20):782-9. doi: 10.1157/13075851. Spanish.

Helpful Links

• Guía de práctica clínica de interacciones farmacológicas potenciales en la atención del adulto mayor
• Drug Interactions in hospitalized patients in the Internal Medicine Hospital University " Dr. Angel Larralde ". June 2014 - December 2015
• Guía de Práctica Clínica Prescripción farmacológica razonada para el adulto mayor
• The hidden world of drug interactions in anesthesia
• Interacciones de drogas e hipertensión arterial

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: November 17, 2021
• First Submitted That Met QC Criteria: November 30, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Hypertension; Drug Interactions; Antihypertensive Agents; Drugs in the emergency room
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Hypertension; Emergencies
• Other Study ID Numbers: R-2020-902-030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: This item has not yet been defined

Drug and device information, study documents

• 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