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

• ClinicalTrials.gov Identifier: NCT02534324
• Recruitment Status: Completed
• First Posted: August 27, 2015
• Results First Posted: March 14, 2016
• Last Update Posted: April 11, 2016
• Sponsor: Chulalongkorn University
• Information provided by (Responsible Party): Khrongwong Musikatavorn, MD., Chulalongkorn University

Study Description

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.

Condition or disease	Intervention/treatment
Hypertension; Emergencies; Asymptomatic Conditions	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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 146 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 7 Days
• Official Title: The Effect of Pre-discharge Blood Pressure on the Follow-up Outcomes After Managing the Patients With Asymptomatic Severe Hypertension in Emergency Department
• Study Start Date: September 2015
• Actual Primary Completion Date: December 2015
• Actual Study Completion Date: December 2015

Groups and Cohorts

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 Name: 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 Name: Blood pressure-lowering drugs

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

Criteria

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.

Contacts and Locations

Locations

Thailand

King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University

Patumwan, Bangkok, Thailand, 10330

Sponsors and Collaborators

Chulalongkorn University

Investigators

• Principal Investigator: Khrongwong Musikatavorn, M.D.; Faculty of Medicine, Chulalongkorn Hospital

More Information

Additional Information:

Publications of Results:

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.

• Responsible Party: Khrongwong Musikatavorn, MD., Dr., Chulalongkorn University
• ClinicalTrials.gov Identifier: NCT02534324
• Other Study ID Numbers: 397/57
• First Posted: August 27, 2015
• Results First Posted: March 14, 2016
• Last Update Posted: April 11, 2016
• Last Verified: February 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Khrongwong Musikatavorn, MD., Chulalongkorn University:

Hypertension; Emergency

Additional relevant MeSH terms:

Hypertension; Emergencies; Asymptomatic Diseases; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Antihypertensive Agents