Interactions Between Antihypertensive Drugs and Drugs Prescribed in the Emergency Room

NCT05140590 | Completed DMC

• 1 other identifier: R-2020-902-030
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Interactions; Hypertension

Keywords

Hypertension; Drug Interactions; Drugs in the emergency room; Antihypertensive Agents

Outcome Measures

Primary Outcomes (3)

• 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. 1. Minors (without clinical condition) 2. Moderate (may cause deterioration of clinical status) 3. Major (can be life-threatening or cause permanent damage) 4. Contraindicated (should not be used simultaneously)

  Duration of hospitalization (15 days)

Secondary Outcomes (3)

• Control of hypertension according to blood pressure figures at admission

  upon admission (2 horas)

• Control of hypertension according to blood pressure figures during hospitalization

  Duration of hospitalization (15 days)

• Control of hypertension according to blood pressure figures at discharge

  At the time of discharge (2-15 days)

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• That they do not know or do not provide complete information on their basic antihypertensive treatment.
• Elimination criteria
• Survey with incomplete pharmacotherapeutic history data.

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Instituto Méxicano del Seguro Social HGZ No.51

Gómez Palacio, Durango, 35025, Mexico

Location

Related Publications (5)

• 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.

  PMID: 17570184 BACKGROUND

• 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.

  PMID: 21640341 BACKGROUND

• 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.

  PMID: 17389673 BACKGROUND

• 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.

  PMID: 30165516 BACKGROUND

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

  PMID: 15927106 BACKGROUND

Related 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

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Lilia E Luque-Esparza, Dra.

  IMSS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Days
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 1, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: February 28, 2022
• Last Updated: March 29, 2022

Record last verified: 2022-03

Locations

ME (1)