Hypertension on EmergenceNCT03484312
Hypertensive Urgency Treatment and Outcomes in a Northeast Thai Population
An observational study of Hypertension on Emergence, run by Khon Kaen University at 1 site in Thailand.
Trial summary
Previous studies have reported a high prevalence of hypertensive (HT) urgency. However, these studies have also reported low rates of serious complications, suggesting that rapid blood pressure (BP) reduction may be unnecessary. There are limited clinical data available on this topic in Asian populations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension on Emergence
- How many people
- 537 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2012to 30 Jun 2017
- How long will I take part?
- 5 Years
- 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: Patients aged 18 years or older who visited the ER with a diagnosis of HT urgency were consecutively enrolled in the study. Patients who were pregnant or lactating, had secondary causes of hypertension were excluded from the study.
Who may be able to join
- Patients aged 18 years or older who visited the ER with a diagnosis of HT urgency
Who cannot join
- Pregnant or lactating
- Secondary hypertension
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Emergency Medicine, Khon Kaen University
Khon Kaen, Muang, 40002
About this study
Official title: Hypertensive Urgency Treatment and Outcomes in a Northeast Thai Population: The Results From the Hypertension Registry Program
Previous studies have reported a high prevalence of hypertensive (HT) urgency. However, these studies have also reported low rates of serious complications, suggesting that rapid blood pressure (BP) reduction may be unnecessary. There are limited clinical data available on this topic in Asian populations. The investigators aimed to determine the basic characteristics, treatment methods, and outcomes in HT urgency patients, both in the emergency room (ER) and at a two-week follow-up.
Read the detailed description
Previous studies have reported the high prevalence of hypertensive (HT) urgency. However, these studies have also reported low rates of serious complications, suggesting that rapid blood pressure (BP) reduction may be unnecessary. There are limited clinical data available on this topic in Asian populations. The investigators aimed to determine the basic characteristics, treatment methods, and outcomes in HT urgency patients, both in the emergency room (ER) and at a two-week follow-up.
This was a cohort study conducted at Srinagarind hospital, a tertiary-care level university hospital in Khon Kaen, Thailand. The data collection period was from January 2012 to June 2017. The Khon Kaen University Ethics Committee in Human Research approved the protocol. Patients aged 18 years or older who visited the ER with a diagnosis of HT urgency were consecutively enrolled in the study. Patients who were pregnant or lactating had secondary causes of HT, or had incomplete medical records were excluded from the study Office BP was measured using an upper arm cuff oscillometric BP device. The appropriate cuff size for each individual's arm circumference was used. Three BP readings were taken at 30-second intervals with the patient in a sitting position after five minutes of rest. The average of three BP measurements was used for analysis.
Baseline characteristic data were shown as the mean and standard deviation (SD) or percentage. An independent sample t-test was used to compare between groups for continuous variables including age, body mass index (BMI), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), time of treatment, and the number of medications being administered. A probability value <0.05 was considered statistically significant. All statistical analyses were performed with SPSS for Mac version 20.0, registered to Khon Kaen University.
- Conditions
- Hypertension on Emergence
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic and diastolic blood pressure (mm Hg)
The investigators aimed to compare systolic and diastolic blood pressure level at baseline and before discharge from the emergency room (ER)
Measured: Up to 24 hours
Discharge status including 1. discharge to home 2. admit to hospital 3. death 4. refer to another hospital
Discharge status from emergency room was observed and collected.
Measured: Up to 24 hours
Secondary outcomes (1)
Systolic and diastolic blood pressure at first hypertension clinic follow up
Office systolic and diastolic blood pressure at first clinic follow up (2 weeks after emergency room visit)
Measured: 2 weeks after discharge from emergency room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start1 Jan 2012
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension on EmergenceStudies 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
- Other
- Enrolment
- 537 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Praew Kotruchin, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484312
- Sponsor's protocol ID
- HE591508
- Status last verified
- Mar 2018
- First submitted
- 15 Mar 2018
- Last updated
- 2 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be provided upon a requested
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertensive Urgency Treatment and Outcomes in a Northeast Thai Population: The Results From the Hypertension Registry Program
- ClinicalTrials.gov ID
- NCT03484312
- Acronym / sponsor ID
- HE591508
- Conditions
- Hypertension on Emergence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 537 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 30 Mar 2018 (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.
Previous studies have reported a high prevalence of hypertensive (HT) urgency. However, these studies have also reported low rates of serious complications, suggesting that rapid blood pressure (BP) reduction may be unnecessary. There are limited clinical data available on this topic in Asian populations. The investigators aimed to determine the basic characteristics, treatment methods, and outcomes in HT urgency patients, both in the emergency room (ER) and at a two-week follow-up.
Detailed description
Previous studies have reported the high prevalence of hypertensive (HT) urgency. However, these studies have also reported low rates of serious complications, suggesting that rapid blood pressure (BP) reduction may be unnecessary. There are limited clinical data available on this topic in Asian populations. The investigators aimed to determine the basic characteristics, treatment methods, and outcomes in HT urgency patients, both in the emergency room (ER) and at a two-week follow-up.
This was a cohort study conducted at Srinagarind hospital, a tertiary-care level university hospital in Khon Kaen, Thailand. The data collection period was from January 2012 to June 2017. The Khon Kaen University Ethics Committee in Human Research approved the protocol. Patients aged 18 years or older who visited the ER with a diagnosis of HT urgency were consecutively enrolled in the study. Patients who were pregnant or lactating had secondary causes of HT, or had incomplete medical records were excluded from the study Office BP was measured using an upper arm cuff oscillometric BP device. The appropriate cuff size for each individual's arm circumference was used. Three BP readings were taken at 30-second intervals with the patient in a sitting position after five minutes of rest. The average of three BP measurements was used for analysis.
Baseline characteristic data were shown as the mean and standard deviation (SD) or percentage. An independent sample t-test was used to compare between groups for continuous variables including age, body mass index (BMI), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), time of treatment, and the number of medications being administered. A probability value <0.05 was considered statistically significant. All statistical analyses were performed with SPSS for Mac version 20.0, registered to Khon Kaen University.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years or older who visited the ER with a diagnosis of HT urgency were consecutively enrolled in the study. Patients who were pregnant or lactating, had secondary causes of hypertension were excluded from the study.
Key inclusion criteria (1 listed)
- Patients aged 18 years or older who visited the ER with a diagnosis of HT urgency
Key exclusion criteria (2 listed)
- Pregnant or lactating
- Secondary hypertension
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
Systolic and diastolic blood pressure (mm Hg)
Time frame: Up to 24 hours
The investigators aimed to compare systolic and diastolic blood pressure level at baseline and before discharge from the emergency room (ER)
Discharge status including 1. discharge to home 2. admit to hospital 3. death 4. refer to another hospital
Time frame: Up to 24 hours
Discharge status from emergency room was observed and collected.
1 secondary outcome
Systolic and diastolic blood pressure at first hypertension clinic follow up
Time frame: 2 weeks after discharge from emergency room
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 2 Apr 2018.
- Individual participant dataSharing planned: Yes. Data will be provided upon a requested
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypertension on Emergence, run by Khon Kaen University at 1 site in Thailand.
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 1 inclusion and 2 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 2 Apr 2018. 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 Thailand. 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?
Systolic and diastolic blood pressure (mm Hg) (time frame: Up to 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2018.