Pharmacological Interactions Between Antihypertensive Regimens and Drugs Prescribed in the Emergency Department of the HGZ 51
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Frequency of IFF by pharmacological mechanism
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of arterial hypertension confirmed that they are hospitalized in the emergency department of HGZ
- •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.
排除标准
- •That they do not know or do not provide complete information on their basic antihypertensive treatment.
- •Elimination criteria
- •Survey with incomplete pharmacotherapeutic history data.
结局指标
主要结局
Frequency of IFF by pharmacological mechanism
时间窗: 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.
Number of theoretical IFFs detected
时间窗: 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
Degree severity of drug interaction detected
时间窗: Duration of hospitalization (15 days)
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)
次要结局
- 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))
研究者
Lilia Edith Luque Esparza
Principal Investigator
Instituto Mexicano del Seguro Social