- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03484312
Hypertensive Urgency Treatment and Outcomes in a Northeast Thai Population
Hypertensive Urgency Treatment and Outcomes in a Northeast Thai Population: The Results From the Hypertension Registry Program
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Muang
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Khon Kaen, Muang, Thailand, 40002
- Emergency Medicine, Khon Kaen University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged 18 years or older who visited the ER with a diagnosis of HT urgency
Exclusion Criteria:
- Pregnant or lactating
- Secondary hypertension
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Up to 24 hours
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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.
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Up to 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systolic and diastolic blood pressure at first hypertension clinic follow up
Time Frame: 2 weeks after discharge from emergency room
|
Office systolic and diastolic blood pressure at first clinic follow up (2 weeks after emergency room visit)
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2 weeks after discharge from emergency room
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HE591508
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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