Asymptomatic Conditions, Emergencies, Hypertension
Conditions
Keywords
Hypertension, Emergency
Brief summary
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.
Detailed description
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.
Interventions
DRUGAntihypertensive 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.
Sponsors
Chulalongkorn University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients ≥18 years old * Systolic BP (SBP) greater or equal to 180 mmHg * Diastolic BP (DBP) ≥ 100 mmHg
Exclusion criteria
* Acute end-organ damage related to severe hypertension that required rapid intravenous antihypertensive drugs for acute treatment involving cardiovascular (acute chest pain, heart failure, acute coronary syndromes, acute aortic syndromes), renal (acute kidney injury), ocular (retinal hemorrhage or hypertensive retinopathy) and central nervous system (seizure, acute cerebrovascular diseases, hypertensive encephalopathy) * Hypertension caused by medical toxicology (e.g. use of sympathomimetic drugs (amphetamine and its derivatives), alcohol withdrawal syndrome * Significantly decreased renal function (serum creatinine ≥ 1.5 mg/dL or creatinine clearance ≤ 30 ml/min) * Pregnant women * Moderate to severe pain (pain score on visual analog scale ≥ 5 centimeters out of 10) * BP decrease to less than 180 mmHg after 10-minute bed rest without any medical treatment * Having concurrent medical conditions that needed hospitalization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Died Within 7 Days After Discharge From the Emergency Department | 7 days | Number of participants who died from hypertension-related events within 7 days after discharge from the emergency department. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Had Major Hypertensive-related Events After Discharge From the Emergency Department | 7 days | 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. |
| Systolic Blood Pressure at Follow-up | 3 to 7 days | Systolic blood pressure at follow-up measured by physicians that were non-investigators and unaware of the study. |
Countries
Thailand
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| High SBP+Antihypertensive Meds Patients with pre-discharge systolic blood pressure at discharge \< 180 mmHg
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. | 98 |
| Severely High SBP+Antihypertensive Meds Patients with pre-discharge systolic blood pressure at discharge \>= 180 mmHg
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. | 48 |
| Total | 146 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 20 | 7 |
| Overall Study | Protocol Violation | 4 | 1 |
Baseline characteristics
| Characteristic | High SBP+Antihypertensive Meds | Severely High SBP+Antihypertensive Meds | Total |
|---|---|---|---|
| Age, Continuous | 65.5 years STANDARD_DEVIATION 15.1 | 64.2 years STANDARD_DEVIATION 15 | 64.5 years STANDARD_DEVIATION 15 |
| Region of Enrollment Thailand | 98 participants | 48 participants | 146 participants |
| Sex: Female, Male Female | 62 Participants | 27 Participants | 89 Participants |
| Sex: Female, Male Male | 36 Participants | 21 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 98 | 0 / 48 |
| serious Total, serious adverse events | 1 / 98 | 0 / 48 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High SBP+Antihypertensive Meds | Number of Participants Who Died Within 7 Days After Discharge From the Emergency Department | 0 participants |
| Severely High SBP+Antihypertensive Meds | Number of Participants Who Died Within 7 Days After Discharge From the Emergency Department | 0 participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High SBP+Antihypertensive Meds | Number of Participants Who Had Major Hypertensive-related Events After Discharge From the Emergency Department | 1 participants |
| Severely High SBP+Antihypertensive Meds | Number of Participants Who Had Major Hypertensive-related Events After Discharge From the Emergency Department | 0 participants |
p-value: 0.49Chi-squared
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High SBP+Antihypertensive Meds | Systolic Blood Pressure at Follow-up | 153.7 mmHg | Standard Deviation 25.7 |
| Severely High SBP+Antihypertensive Meds | Systolic Blood Pressure at Follow-up | 160.9 mmHg | Standard Deviation 23 |
p-value: 0.15t-test, 2 sided