Akershus Cardiac Examination (ACE) 4 Study: Pragmatic Randomized Controlled Trial of Early Biomarker Measurements and Structured Feedback in Unselected Patients With Tachypnea
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 574
- 试验地点
- 2
- 主要终点
- Composite of all-cause hospital readmission or all-cause mortality
研究概览
简要总结
Patients hospitalized with tachypnea, defined as respiratory rate ≥20/ min, have substantial mortality and may suffer from different conditions, including acute heart failure (HF). Symptoms of HF can be difficult to identify and ~15% of patients with HF will not be correctly diagnosed by the treating physician in the Emergency Department. Biomarkers like B-type natriuretic peptides and cardiac troponins improve diagnostic accuracy and risk stratification. Whether early, structured biomarker assessment and structured feedback in the patient's electronic health records improve management and outcomes among unselected patients with tachypnea have previously not been explored in a randomized controlled trial.
The main research question of the study is to determine whether early structured biomarker assessment in unselected patients with tachypnea extends the time to the first event for either (1) all-cause readmission or (2) all-cause mortality; i.e. time to the combined endpoint, compared to the current strategy/standard care
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years old
- •Tachypnea (respiratory rate ≥20/min)
- •Admission to Departments under the Division of Medicine at Akershus University Hospital, except the Department of Neurology
- •<24 h from hospital admittance to inclusion in the study
- •Signed written informed consent during the initial phase of the hospitalization
排除标准
- •Previously included into the study (in case of patients presenting with a second hospitalization during the study period)
- •Known or suspected cancer outside of local control, documented in medical records, at the time of patient inclusion or diagnosed in relation to the index hospitalization
- •Neurological condition with short life expectancy; e.g. ALS, documented in medical records during screening prior to study entry
- •Other non-cardiac disease with life expectancy below 1 year, documented in medical records during screening prior to study entry
- •Obvious non-cardiac cause for tachypnea based on medical records and clinical findings during screening prior to study entry; e.g. anaphylaxis in young patient with known allergy, dyspnea after direct chest trauma, or young patient with fever and positive Covid-19 test on admission.
- •Patient assessed as non-Internal Medicine patient; e.g. surgical patient
- •Patients unwilling or unable to comply with the protocol, including Glasgow Coma Scale <13 on the time of study inclusion
- •Patients that are intubated for invasive ventilatory therapy before or shortly after hospital admission
- •History of non-compliance to medical management and patients who are considered potentially unreliable, based on documentation in medical records, during screening prior to study entry
- •History or evidence of alcohol or drug abuse with the last 12 months, based on medical records and clinical findings during screening prior to study entry, that will influence study participation
- •Any surgical or medical condition, based on medical records and clinical findings during screening prior to study entry, that will impair the ability of the patient to participate in the study
研究组 & 干预措施
Early biomarker-based cardiological assessment and structured feedback in the EHR
We will perform cardiac biomarker testing with NT-proBNP and hs-cTnT measurements on emergency department admission in all participants, regardless of randomization status. The results will be provided in the patient's EHR, regardless of randomization status. For patients randomized to the intervention group, we will provide a note in the patient's EHR that includes assessment of probability that myocardial injury or dysfunction are the underlying pathophysiology responsible for tachypnea, as evaluated by the cardiac biomarker algorithm of the study. We will inform on general recommendations for work up and treatment.
干预措施: Early biomarker-based cardiological assessment (Other)
Standard of care
Routine standard of care according to the treating physician
结局指标
主要结局
Composite of all-cause hospital readmission or all-cause mortality
时间窗: 12 months after discharge from index hospitalization
Composite of all-cause hospital readmission or all-cause mortality after discharge from index hospitalization
次要结局
- Length of stay in Intensive Care Unit/Medical Intensive Care Unit/Cardiac Intensive Care Unit(From admission to discharge of index hospitalization, assessed up to 12 months)
- All-cause mortality(From admission to discharge of index hospitalization, assessed up to 12 months)
- Hospital length of stay(From admission to discharge of index hospitalization, assessed up to 12 months)
- Time to all-cause readmission(12 months after discharge from index hospitalization)
- 30-day all-cause readmission(30-days after discharge from index hospitalization)
- Number of all-cause readmission(12 months after discharge from index hospitalization)
- Difference in cardiac biomarker concentrations during index hospitalization(From admission to discharge of index hospitalization, assessed up to 12 months)
- Cost-utility(From admission to discharge of index hospitalization, assessed up to 12 months)
- Total cost of hospitalization(From admission to discharge of index hospitalization, assessed up to 12 months)
- Difference in guideline-defined medical therapy for heart failure(From admission to discharge of index hospitalization, assessed up to 12 months)
- All-cause mortality(12 months after discharge from index hospitalization)
研究者
Magnus Nakrem Lyngbakken
Associate professor
University Hospital, Akershus