Hypertensive Urgency Treatment and Outcomes in a Northeast Thai Population

Hypertension on Emergence Clinical Trial

Official title:

Hypertensive Urgency Treatment and Outcomes in a Northeast Thai Population: The Results From the Hypertension Registry Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03484312
• Other study ID #: HE591508
• Status: Completed
• First received: March 15, 2018
• Last updated: March 29, 2018
• Start date: January 1, 2012
• Est. completion date: June 30, 2017

Study information

• Verified date: March 2018
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 537
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension on Emergence

Locations

Country	Name	City	State
Thailand	Emergency Medicine, Khon Kaen University	Khon Kaen	Muang

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Up to 24 hours
Primary	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.	Up to 24 hours
Secondary	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)	2 weeks after discharge from emergency room