Clinical Outcome and Cost-effectiveness of Reduced Noradrenaline by Using a Lower Blood Pressure Target in Patients With Cardiogenic Shock From Acute Myocardial Infarction
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 776
- 试验地点
- 1
- 主要终点
- Mortality and renal failure
研究概览
简要总结
Rationale: Pump failure due to acute myocardial infarction (AMI) can lead to cardiogenic shock (CS): a state of low blood flow to end-organs with subsequent multi-organ failure that is associated with high mortality rated. The first line pharmacologic treatment strategy in CS is noradrenaline. This vasopressor drug is used to maintain adequate blood pressures. The assumption is that a mean arterial blood pressure (MAP) ≥ 65 mmHg will improve flow and thereby tissue perfusion of myocardium and other tissues (e.g. renal). However, there is no evidence that an increase in MAP, if achieved by noradrenaline, leads to greater end-organ blood flow and better outcomes.
Objective: With this study the investigators aim to investigate the (cost-)effectiveness of reduced noradrenaline in patients with CS by using a lower MAP target of ≥ 55 mmHg, compared to ≥ 65 mmHg. The investigators hypothesize that reduced use of noradrenaline will improve overall survival and decrease renal failure requiring renal replacement therapy.
Study design: Open label, randomized controlled multicenter trial
Study population: Adults patients with CS due to AMI
Intervention: Treatment strategy of reduced noradrenaline, by using a lower MAP target ( ≥ 55 mmHg).
Main study endpoint: composite of all-cause mortality and severe renal failure leading to renal replacement therapy within 30-days after randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Acute myocardial infarction, STEMI or NSTEMI
- •Early revascularization by PCI
- •Cardiogenic shock, characterized by:
- •I. a. Systolic blood pressure (SBP) ≤ 90 mmHg for > 30 minutes, OR b. Use of drugs to maintain SBP > 90 mmHg at randomization.
- •II. Clinical signs of impaired organ perfusion with at least one of the following criteria:
- •Altered mental status
- •Cold, clammy skin and extremities
- •Oliguria with urine output < 30ml/hour
- •Serum lactate > 2.0 mmol/L
- •III. Clinical signs of pulmonary congestion
排除标准
- •Resuscitation > 30 minutes
- •Mechanical cause of cardiogenic shock (e.g. papillary muscle rupture, ventricular septal rupture)
- •Onset of shock > 12 hours
- •Imminent need for mechanical circulatory support (i.e. ECPR)
- •Women <45 years
研究组 & 干预措施
Reduced noradrenaline (MAP ≥ 55 mmHg)
干预措施: Reduced noradrenaline use (Drug)
结局指标
主要结局
Mortality and renal failure
时间窗: 30-days
Composite of all-cause mortality and severe renal failure leading to renal replacement therapy
次要结局
- Blood pressure (systolic and diastolic)(The first 24 hours)
- Heart rate(The first 24 hours)
- Enzymatic infarct size, measured by hs-Troponin T(0, 6, 12, 24, 36 and 72 hours)
- Ejection fraction, percent(72 hours and 1 year)
- Renal function(1 year)
- Enzymatic infarct size, measured by CK-MB(0, 6, 12, 24, 36 and 72 hours)
- Duration of mechanical ventilation(Recorded after ICU/CCU discharge, assessed up to 60 days)
- Need for vasopressors / inotropes(Recorded after ICU/CCU discharge, assessed up to 60 days)
- Need for mechanical circulatory support(Recorded after ICU/CCU discharge, assessed up to 60 days)
- Cost-effectiveness(1-year)
研究者
J.P.S Henriques
Prof. dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)