An observational study in Hypertension, Emergencies and Asymptomatic Conditions, sponsored by Chulalongkorn University. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-11.
Sponsored by Chulalongkorn University · Observational
The current guideline of asymptomatic severe hypertension (ASH) treatment in emergency department (ED) recommends through low level of evidence that the patients should not be rapidly decreased their BP in ED but instead receive oral antihypertensive treatment and close outpatient follow-up is needed. Unfortunately, there was some ambiguity in the time point of BP measurement in ED described in the past literature because high BP on ED admission may significantly decrease within hours without any medications. The importance of pre-ED discharge BP, which can still be critically high, that may affect the follow-up outcome has never been investigated. The study aim of this study is to evaluate the physicians' treatment strategies as well as immediate clinical outcomes between patients with severely- and moderately-elevated pre-discharge BP after management of ASH its in ED during the recent recommendation. The secondary outcome is to compare the BP at follow-up in these two groups.
The investigators will follow the patients with asymptomatic severe hypertension who attend ED of King Chulalongkorn Memorial Hospital (KCMH), an urban, 1,500-bed, university-affiliated, tertiary care hospital as well as treatment strategies. A management strategy whether to start the drugs in ED with or without a period of observation or immediately after discharge without any observation depends on the treating physicians' judgment. The investigators predefined the pre-discharge BP at ED into two groups; high BP (pre-discharge SBP \< 180 mmHg) and severely high BP (pre-discharge SBP >= 180mmHg) groups. Every eligible patient was scheduled for the internal medicine clinic for continuous care of the high blood pressure within 3-7 days after discharge. Medical records were retrieved for the follow-up BP, compliance and associated adverse events at the clinic. The investigators will make telephone follow-ups to the participants or their contact personnel in every case at 10 days after ED presentation to identify the deceased cases or those with major morbidity as well as the compliance to their medications.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 146 is below the median of 210 across 1,359 observational studies indexed under Hypertension.
Browse Hypertension studies →Chulalongkorn University is the lead sponsor of 312 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients (≥18 years old) who presented in our ED with systolic BP (SBP) greater or equal to 180 mmHg and diastolic BP (DBP) ≥ 100 mmHg were consecutively enrolled in this study.
Exclusion Criteria:
Patients with pre-discharge systolic blood pressure at discharge \< 180 mmHg
Drug: Antihypertensive meds
Patients with pre-discharge systolic blood pressure at discharge \>= 180 mmHg
Drug: Antihypertensive meds
Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians.
Also known as: Blood pressure-lowering drugs
Number of Participants Who Died Within 7 Days After Discharge From the Emergency Department
Number of participants who died from hypertension-related events within 7 days after discharge from the emergency department.
Time frame: 7 days
Number of Participants Who Had Major Hypertensive-related Events After Discharge From the Emergency Department
Participants who had major hypertensive-related events defined by those who had one or more of the followings: acute chest pain, heart failure, acute coronary syndromes, acute aortic syndromes, retinal/vitreous hemorrhage, hypertensive retinopathy, seizure, acute cerebrovascular diseases, hypertensive encephalopathy, which occurred within 7 days after discharge from emergency department.
Time frame: 7 days
Systolic Blood Pressure at Follow-up
Systolic blood pressure at follow-up measured by physicians that were non-investigators and unaware of the study.
Time frame: 3 to 7 days
Patients \>= 18 years old who presented in ED with systolic BP \>=180 mmHg and diastolic BP \>= 100 mmHg were enrolled. The patients with minor chief complaints that were not related to severe hypertension or those who presented to hospital for routine outpatient visits and were referred to ED due to severe hypertension were included.
| Milestone | High SBP+Antihypertensive Meds | Severely High SBP+Antihypertensive Meds |
|---|---|---|
| Started | 98 | 48 |
| Completed | 73 | 40 |
| Not completed | 25 | 8 |
| Withdrew: Protocol violation | 4 | 1 |
| Withdrew: Lost to follow-up | 20 | 7 |
| Withdrew: Adverse event | 1 | 0 |
Number of participants who died from hypertension-related events within 7 days after discharge from the emergency department.
| participants | High SBP+Antihypertensive Meds | Severely High SBP+Antihypertensive Meds |
|---|---|---|
| Number of Participants Who Died Within 7 Days After Discharge From the Emergency Department | 0 | 0 |
Participants who had major hypertensive-related events defined by those who had one or more of the followings: acute chest pain, heart failure, acute coronary syndromes, acute aortic syndromes, retinal/vitreous hemorrhage, hypertensive retinopathy, seizure, acute cerebrovascular diseases, hypertensive encephalopathy, which occurred within 7 days after discharge from emergency department.
| participants | High SBP+Antihypertensive Meds | Severely High SBP+Antihypertensive Meds |
|---|---|---|
| Number of Participants Who Had Major Hypertensive-related Events After Discharge From the Emergency Department | 1 | 0 |
Systolic blood pressure at follow-up measured by physicians that were non-investigators and unaware of the study.
| mmHg | High SBP+Antihypertensive Meds | Severely High SBP+Antihypertensive Meds |
|---|---|---|
| Systolic Blood Pressure at Follow-up | 153.7 ± 25.7 | 160.9 ± 23.0 |
Collected over 7 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High SBP+Antihypertensive Meds | — | 1/98 (1%) | 0/98 (0%) |
| Severely High SBP+Antihypertensive Meds | — | 0/48 (0%) | 0/48 (0%) |
| Event | High SBP+Antihypertensive Meds | Severely High SBP+Antihypertensive Meds |
|---|---|---|
| Aortic aneurysmCardiac disorders | 1/98 | 0/48 |
| Age, Continuous(years) | High SBP+Antihypertensive Meds | Severely High SBP+Antihypertensive Meds | Total |
|---|---|---|---|
| Mean | 65.5 ± 15.1 | 64.2 ± 15.0 | 64.5 ± 15.0 |
| Sex: Female, Male(Participants) | High SBP+Antihypertensive Meds | Severely High SBP+Antihypertensive Meds | Total |
|---|---|---|---|
| Female | 62 | 27 | 89 |
| Male | 36 | 21 | 57 |
| Region of Enrollment(participants) | High SBP+Antihypertensive Meds | Severely High SBP+Antihypertensive Meds | Total |
|---|---|---|---|
| Thailand | 98 | 48 | 146 |
Plan to share: No
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Chulalongkorn University