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

NCT02534324 | Completed Results

• 1 other identifier: 397/57
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Emergencies; Asymptomatic Conditions

Keywords

Hypertension; Emergency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

High SBP+antihypertensive meds

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

Drug: Antihypertensive meds

Severely high SBP+antihypertensive meds

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

Drug: Antihypertensive meds

Interventions

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.

Also known as: Blood pressure-lowering drugs

High SBP+antihypertensive meds; Severely high SBP+antihypertensive meds

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult patients ≥18 years old
• Systolic BP (SBP) greater or equal to 180 mmHg
• Diastolic BP (DBP) ≥ 100 mmHg

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University

Patumwan, Bangkok, 10330, Thailand

Location

Related Publications (1)

• 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.

  PMID: 26874395 RESULT

MeSH Terms

Conditions

Hypertension; Emergencies; Asymptomatic Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The results may not be generalizable to other centers with different treatment practices. We still had a considerable percentage of patients who were lost-to-follow-up that may have affected the results. The size of population was relatively small.

Results Point of Contact

• Title: Dr. Khrongwong Musikatavorn
• Organization: Faculty of Medicine, Chulalongkorn University

Khrongwong.m@chulahospital.org

+66818390511

Study Officials

• Khrongwong Musikatavorn, M.D.

  Faculty of Medicine, Chulalongkorn Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: August 27, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 11, 2016
• Results First Posted: March 14, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)