Trial Outcomes & Findings for The Effect of Pre-discharge Blood Pressure of Patients With Asymptomatic Severe Hypertension in Emergency Department (NCT NCT02534324)
NCT ID: NCT02534324
Last Updated: 2016-04-11
Results Overview
Number of participants who died from hypertension-related events within 7 days after discharge from the emergency department.
Recruitment status
COMPLETED
Target enrollment
146 participants
Primary outcome timeframe
7 days
Results posted on
2016-04-11
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
98
|
48
|
|
Overall Study
COMPLETED
|
73
|
40
|
|
Overall Study
NOT COMPLETED
|
25
|
8
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
20
|
7
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
The Effect of Pre-discharge Blood Pressure of Patients With Asymptomatic Severe Hypertension in Emergency Department
Baseline characteristics by cohort
| Measure |
High SBP+Antihypertensive Meds
n=98 Participants
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.
|
Severely High SBP+Antihypertensive Meds
n=48 Participants
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.
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 15.1 • n=5 Participants
|
64.2 years
STANDARD_DEVIATION 15.0 • n=7 Participants
|
64.5 years
STANDARD_DEVIATION 15.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
98 participants
n=5 Participants
|
48 participants
n=7 Participants
|
146 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 daysNumber of participants who died from hypertension-related events within 7 days after discharge from the emergency department.
Outcome measures
| Measure |
High SBP+Antihypertensive Meds
n=98 Participants
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.
|
Severely High SBP+Antihypertensive Meds
n=48 Participants
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.
|
|---|---|---|
|
Number of Participants Who Died Within 7 Days After Discharge From the Emergency Department
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 7 daysParticipants 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.
Outcome measures
| Measure |
High SBP+Antihypertensive Meds
n=98 Participants
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.
|
Severely High SBP+Antihypertensive Meds
n=48 Participants
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.
|
|---|---|---|
|
Number of Participants Who Had Major Hypertensive-related Events After Discharge From the Emergency Department
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 3 to 7 daysSystolic blood pressure at follow-up measured by physicians that were non-investigators and unaware of the study.
Outcome measures
| Measure |
High SBP+Antihypertensive Meds
n=73 Participants
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.
|
Severely High SBP+Antihypertensive Meds
n=40 Participants
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.
|
|---|---|---|
|
Systolic Blood Pressure at Follow-up
|
153.7 mmHg
Standard Deviation 25.7
|
160.9 mmHg
Standard Deviation 23.0
|
Adverse Events
High SBP+Antihypertensive Meds
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Severely High SBP+Antihypertensive Meds
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High SBP+Antihypertensive Meds
n=98 participants at risk
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.
|
Severely High SBP+Antihypertensive Meds
n=48 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Aortic aneurysm
|
1.0%
1/98 • Number of events 1 • 7 days
|
0.00%
0/48 • 7 days
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Khrongwong Musikatavorn
Faculty of Medicine, Chulalongkorn University
Phone: +66818390511
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place