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

The Effect of Pre-discharge Blood Pressure on the Follow-up Outcomes After Managing the 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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Emergencies; Asymptomatic Conditions
• Intervention / Treatment: Drug: Antihypertensive meds

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.

• Study Type: Observational
• Enrollment (Actual): 146

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Patumwan, Bangkok, Thailand, 10330
      • King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
High SBP+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.; Other Names: Blood pressure-lowering drugs
Severely high SBP+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.; Other Names: Blood pressure-lowering drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	3 to 7 days

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Principal Investigator: Khrongwong Musikatavorn, M.D., Faculty of Medicine, Chulalongkorn Hospital

Publications and helpful links

General Publications

• Nakprasert P, Musikatavorn K, Rojanasarntikul D, Narajeenron K, Puttaphaisan P, Lumlertgul S. Effect of predischarge blood pressure on follow-up outcomes in patients with severe hypertension in the ED. Am J Emerg Med. 2016 May;34(5):834-9. doi: 10.1016/j.ajem.2016.01.013. Epub 2016 Jan 21.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: August 25, 2015
• First Submitted That Met QC Criteria: August 25, 2015
• First Posted (Estimate): August 27, 2015

Study Record Updates

• Last Update Posted (Estimate): April 11, 2016
• Last Update Submitted That Met QC Criteria: March 13, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Hypertension; Emergency
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Hypertension; Emergencies; Asymptomatic Diseases; Antihypertensive Agents
• Other Study ID Numbers: 397/57

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO