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临床试验/NCT02534324
NCT02534324已完成不适用

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 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
146
试验地点
1
主要终点
Number of Participants Who Died Within 7 Days After Discharge From the Emergency Department

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

High SBP+antihypertensive meds

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

干预措施: Antihypertensive meds (Drug)

Severely high SBP+antihypertensive meds

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

干预措施: Antihypertensive meds (Drug)

结局指标

主要结局

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

时间窗: 7 days

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Khrongwong Musikatavorn, MD.

Dr.

Chulalongkorn University

研究点 (1)

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