Use of Dobutamine in Patients With Sepsis and Maintained Hypoperfusion After Initial Volemic Resuscitation.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Serum creatine on the third day
研究概览
简要总结
This phase 2 study aim to investigate the effect of dobutamine in patients with sepsis/ septic shock after fluid resuscitation and with hypoperfusion (lactate and central venous oxygen saturation or prolonged capillary refill time) on renal function as compared with usual care.
详细描述
In this phase 2 study patients with sepsis/ septic shock and signs of persistent hypoperfusion after fluid resuscitation will be randomized to receive either dobutamine or no intervention in addition to usual care. Dobutamine will be used for 48 hours. Hypoperfusion will be assessed by altered lactate levels and a low SvO2 or prolonged capillary refill time. Both arms will receive usual care according to the Surviving Sepsis Campaign guidelines. Dobutamine dosis will be adjusted to achieve improvement in the perfusion parameters according to a pre specified protocol. Pre specified criteria will be used to stop the drug for safety. The primary outcome will be creatinine at Day 3. Other secondary and safety outcomes will also be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Over 18 years old
- •Patient with sepsis (suspected or confirmed) for less than 48 hours with:
- •Adequate volume resuscitation with 30 ml/kg of crystalloid solution or assessment by the attending physician that fluid resuscitation is no longer indicated Signs of hypoperfusion for less than 12 hours assessed by arterial lactate over two times the reference value and central venous saturation (SvcO2) less than 66% OR capillary refill time greater than 3 seconds.
排除标准
- •Pregnancy
- •Risk of imminent death within the next 12 hours in the opinion of the attending physician
- •Patients under end of live care
- •Previous congestive heart failure in functional class IV and/or dependence for all basic activities of daily living
- •Hemoglobin levels below 7.0 g/dL
- •Current use of dobutamine
- •Patients in renal replacement therapy
研究组 & 干预措施
Dobutamine
Patients in this group will receive, in addition to usual care, dobutamine in continuous infusion for a period of 48 hours after the randomization.
干预措施: Dobutamine (Drug)
结局指标
主要结局
Serum creatine on the third day
时间窗: 3 days
Serum creatinine corrected by fluid balance on the third day
次要结局
- Vasopressors free days up to day 7(7 days)
- ICU mortality(60 days)
- Renal replacement therapy up to day 7(7 days)
- Hospital mortality(60 days)
- ICU free days up to day 28th(28 days)
- Severe arrhythmia(7 days)
研究者
Flavia Ribeiro Machado
Federal University of São Paulo
Federal University of São Paulo