Interactions Between Antihypertensive Drugs and Drugs Prescribed in the Emergency Room

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05140590
• Other study ID #: R-2020-902-030
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: March 2022
• Source: Instituto Mexicano del Seguro Social
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 28, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Drug Interactions
• Emergencies
• Hypertension

Locations

Country	Name	City	State
Mexico	Instituto Méxicano del Seguro Social HGZ No.51	Gomez Palacio	Durango

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

References & Publications (5)

Amariles P, Giraldo NA, Faus MJ. [Clinical relevance of drug interactions]. Med Clin (Barc). 2007 Jun 2;129(1):27-35. Review. Spanish. — View Citation

Horn JR, Hansten PD, Chan LN. Proposal for a new tool to evaluate drug interaction cases. Ann Pharmacother. 2007 Apr;41(4):674-80. Epub 2007 Mar 27. — View Citation

Iniesta-Navalón C, Urbieta-Sanz E, Gascón-Cánovas 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. — View Citation

Morales-Olivas FJ, Estañ L. [Antihypertensive drug-drug interactions]. Med Clin (Barc). 2005 May 28;124(20):782-9. Review. Spanish. — View Citation

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. Erratum in: Eur Heart J. 2019 Feb 1;40(5):475. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)

External Links

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