Early Goal Directed Therapy Using a Physiological Holistic View. A Multicenter Study in Latin America: The ANDROMEDA-SHOCK Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 424
- 试验地点
- 2
- 主要终点
- All-cause of mortality
研究概览
简要总结
Septic shock is a highly lethal condition associated with a mortality risk of 30 to 60%. Optimizing tissue perfusion and oxygenation is the aim to decrease mortality and morbidity in septic shock patients.
Persistent hyperlactatemia after initial resuscitation is particularly difficult to interpret, although optimizing systemic blood flow might reverse ongoing hypoperfusion. Nevertheless, if persistent hyperlactatemia is caused by non-hypoperfusion-related mechanisms, then sustained efforts aimed at increasing cardiac output (CO) could lead to detrimental effects of excessive fluids or inotropes. Another potential alternative resuscitation target is peripheral perfusion as assessed by capillary refill time (CRT), mottling score or central-to-toe temperature differences. Reversal of abnormal peripheral perfusion might represent improvement in tissue hypoperfusion with the advantage of a faster recovery than lactate.
Hypothesis: Peripheral perfusion guided resuscitation in septic shock is associated with lower mortality, less organ dysfunctions, less mechanical ventilation (MV), less vasopressor load, and less renal replacement therapies than a lactate-targeted resuscitation strategy.
Main Objective To test if peripheral perfusion targeted resuscitation in septic shock is associated with lower 28-day mortality than a lactate targeted resuscitation.
Design: Multicenter, Parallel Assignment randomized controlled study, conducted under supervision of an independent Data Safety Monitoring Board (DSMB).
Interventions:
- Active Comparator- Peripheral Perfusion guided resuscitation
- Active Comparator- Lactate guided resuscitation
Randomization: 1:1 the randomization using a block size of eight will be stratified according to participating centers.
Trial size: 400 randomized patients in 30 ICUs.
详细描述
Early Goal Directed Therapy using a Physiological Holistic View. A multicenter study in Latin America: The ANDROMEDA-SHOCK Study
Hypothesis Peripheral perfusion guided resuscitation in septic shock is associated with lower mortality, less organ dysfunctions, less mechanical ventilation (MV), less vasopressor load, and less renal replacement therapies than a lactate-targeted resuscitation strategy.
Using a holistic view of optimizing tissue perfusion and oxygenation the investigators aim to decrease mortality and morbidity in septic shock patients.
A. Background Septic shock is a highly lethal condition associated with a mortality risk of 30 to 60%. It is currently the most frequent cause of death in the intensive care unit (ICU) as the investigators demonstrated in a recent Chilean prevalence study. Several pathogenic factors such as hypovolemia, myocardial depression, vasoplegia, and microcirculatory abnormalities can induce progressive tissue hypoperfusion in severe cases. In this context, persistent hyperlactatemia has been traditionally considered as the hallmark of ongoing tissue hypoxia during septic shock, and therefore lactate normalization is recommended as a resuscitation target by the Surviving Sepsis Campaign (SSC).
Pathophysiologic determinants of persistent hyperlactatemia
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Septic shock diagnosed at ICU admission according to the Sepsis-3 Consensus Conference, (basically septic patients with hypotension requiring norepinephrine (NE) to maintain a mean arterial pressure (MAP) of ≥ 65 mmHg, and serum lactate levels > 2 mmol/l after initial fluid resuscitation with at least 20/ml kg in one hour.
排除标准
- •Pregnancy
- •Anticipated surgery or dialysis procedure during the first 8h after septic shock diagnosis
- •Do-not-resuscitate status
- •Child B or C liver cirrhosis
- •Active bleeding
- •Acute hematological malignancy
- •Severe concomitant acute respiratory distress syndrome (ARDS)
- •More than 4h after officially meeting septic shock criteria
研究组 & 干预措施
Peripheral Perfusion guided resuscitation
Resuscitation will be aimed at normalization of capillary refill time.
干预措施: Peripheral Perfusion guided resuscitation (Other)
Lactate guided resuscitation
Resuscitation will be aimed at normalization or significant decrease in lactate levels.
干预措施: Lactate guided resuscitation (Other)
结局指标
主要结局
All-cause of mortality
时间窗: 28 days
All cause of mortality.
次要结局
- Variations in Sequential Organ failure Assessment (SOFA)(At 8, 24, 48 and 72 hours)
- Need of mechanical ventilation(28 days)
- Need of renal replacement therapies (RRT)(28 days)
- Days free of MV, vasopressors and RRT(28 days)
研究者
Glenn Hernández
Tenured Professor
Pontificia Universidad Catolica de Chile