Clinical trial NCT05140590: Interactions Between Antihypertensive Drugs and Drugs Prescribed in the Emergency Room
Official title: Pharmacological Interactions Between Antihypertensive Regimens and Drugs Prescribed in the Emergency Department of the HGZ 51
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug Interactions
Hypertension
Keywords: Hypertension
Drug Interactions
Drugs in the emergency room
Antihypertensive Agents
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2021-12-01
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of theoretical IFFs detected
timeFrame: Duration of hospitalization (15 days)
measure: Frequency of IFF by pharmacological mechanism
timeFrame: Duration of hospitalization (15 days)
measure: Degree severity of drug interaction detected
timeFrame: Duration of hospitalization (15 days)
Secondary outcomes:
measure: Control of hypertension according to blood pressure figures at admission
timeFrame: upon admission (2 horas)
measure: Control of hypertension according to blood pressure figures during hospitalization
timeFrame: Duration of hospitalization (15 days)
measure: Control of hypertension according to blood pressure figures at discharge
timeFrame: At the time of discharge (2-15 days)
Other outcomes:
Locations:
city: Gomez Palacio
country: Mexico
facility: Instituto Méxicano del Seguro Social HGZ No.51
state: Durango
Study officials:
affiliation: IMSS
name: Lilia E Luque-Esparza, Dra.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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. doi: 10.1345/aph.1H423. Epub 2007 Mar 27.
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. No abstract available.
citation: Morales-Olivas FJ, Estan L. [Antihypertensive drug-drug interactions]. Med Clin (Barc). 2005 May 28;124(20):782-9. doi: 10.1157/13075851. Spanish.