The Effect of Pre-discharge Blood Pressure of Patients With Asymptomatic Severe Hypertension in Emergency Department

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension Asymptomatic Conditions Asymptomatic Diseases Cardiovascular Diseases Disease Attributes Emergencies Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University

Patumwan, Bangkok, 10330, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Antihypertensive meds

Drug

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.

Other names: Blood pressure-lowering drugs

Primary outcomes

Number of Participants Who Died Within 7 Days After Discharge From the Emergency Department

Time frame: 7 days

Number of participants who died from hypertension-related events within 7 days after discharge from the emergency department.

Secondary outcomes

Number of Participants Who Had Major Hypertensive-related Events After Discharge From the Emergency Department

Time frame: 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

Time frame: 3 to 7 days

Systolic blood pressure at follow-up measured by physicians that were non-investigators and unaware of the study.

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

The Effect of Pre-discharge Blood Pressure on the Follow-up Outcomes After Managing the Patients With Asymptomatic Severe Hypertension in Emergency Department

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Aug 27, 2015
Registry last updated: Apr 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed