Skip to main content
Clinical Trials/NCT02534324
NCT02534324
Completed
Not Applicable

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

Chulalongkorn University1 site in 1 country146 target enrollmentStarted: September 2015Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
146
Locations
1
Primary Endpoint
Number of Participants Who Died Within 7 Days After Discharge From the Emergency Department

Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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.

Arms & Interventions

High SBP+antihypertensive meds

Patients with pre-discharge systolic blood pressure at discharge < 180 mmHg

Intervention: Antihypertensive meds (Drug)

Severely high SBP+antihypertensive meds

Patients with pre-discharge systolic blood pressure at discharge >= 180 mmHg

Intervention: Antihypertensive meds (Drug)

Outcomes

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(7 days)
  • Systolic Blood Pressure at Follow-up(3 to 7 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Khrongwong Musikatavorn, MD.

Dr.

Chulalongkorn University

Study Sites (1)

Loading locations...

Similar Trials