Drug InteractionsNCT05140590
Interactions Between Antihypertensive Drugs and Drugs Prescribed in the Emergency Room
An observational study of Drug Interactions and Hypertension, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Interactions, Hypertension
- How many people
- 53 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jan 2021to 28 Feb 2022
- How long will I take part?
- 15 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Beneficiaries with a history of a diagnosis of arterial hypertension who are hospitalized in the emergency service of the HGZ 51.
Who may be able to join
- 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.
Who cannot join
- That they do not know or do not provide complete information on their basic antihypertensive treatment.
- Elimination criteria
- Survey with incomplete pharmacotherapeutic history data.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Méxicano del Seguro Social HGZ No.51
Gómez Palacio, Durango, 35025
About this study
Official title: 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.
Read the 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.
- Conditions
- Drug Interactions, Hypertension
- Keywords
- Hypertension, Drug Interactions, Drugs in the emergency room, Antihypertensive Agents
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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)
Measured: Duration of hospitalization (15 days)
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: At the time of discharge (2-15 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2021
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Drug InteractionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lilia Edith Luque Esparza, Instituto Mexicano del Seguro Social
- Investigators
- Lilia E Luque-Esparza, Dra., Principal investigator, IMSS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140590
- Sponsor's protocol ID
- R-2020-902-030
- Status last verified
- Mar 2022
- First submitted
- 17 Nov 2021
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This item has not yet been defined
Publications
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.
PubMed 17570184Iniesta-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.
PubMed 21640341Horn 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.
PubMed 17389673Williams 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.
PubMed 30165516Morales-Olivas FJ, Estan L. [Antihypertensive drug-drug interactions]. Med Clin (Barc). 2005 May 28;124(20):782-9. doi: 10.1157/13075851. Spanish.
PubMed 15927106
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological Interactions Between Antihypertensive Regimens and Drugs Prescribed in the Emergency Department of the HGZ 51
- ClinicalTrials.gov ID
- NCT05140590
- Acronym / sponsor ID
- R-2020-902-030
- Conditions
- Drug Interactions, Hypertension
- Keywords
- Hypertension, Drug Interactions, Drugs in the emergency room, Antihypertensive Agents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Beneficiaries with a history of a diagnosis of arterial hypertension who are hospitalized in the emergency service of the HGZ 51.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- That they do not know or do not provide complete information on their basic antihypertensive treatment.
- Elimination criteria
- Survey with incomplete pharmacotherapeutic history data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of theoretical IFFs detected
Time frame: 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
Frequency of IFF by pharmacological mechanism
Time frame: 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.
Degree severity of drug interaction detected
Time frame: 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)
3 secondary outcomes
Control of hypertension according to blood pressure figures at admission
Time frame: upon admission (2 horas)
Control of hypertension according to blood pressure figures during hospitalization
Time frame: Duration of hospitalization (15 days)
Control of hypertension according to blood pressure figures at discharge
Time frame: At the time of discharge (2-15 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Background: PubMed 17570184Amariles 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.
- Background: PubMed 21640341Iniesta-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.
- Background: PubMed 17389673Horn 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.
- Background: PubMed 30165516Williams 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.
- Background: PubMed 15927106Morales-Olivas FJ, Estan L. [Antihypertensive drug-drug interactions]. Med Clin (Barc). 2005 May 28;124(20):782-9. doi: 10.1157/13075851. Spanish.
- Guía de práctica clínica de interacciones farmacológicas potenciales en la atención del adulto mayorLink provided by the sponsor.
- Drug Interactions in hospitalized patients in the Internal Medicine Hospital University " Dr. Angel Larralde ". June 2014 - December 2015Link provided by the sponsor.
- Guía de Práctica Clínica Prescripción farmacológica razonada para el adulto mayorLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. This item has not yet been defined
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lilia E Luque-Esparza, Dra. principal investigator
IMSS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Interactions and Hypertension, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of theoretical IFFs detected (time frame: Duration of hospitalization (15 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05140590, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.