What Should be the Next Vasopressor for Severe Septic Shock Patients? Methylene Blue or Terlipressin
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- mortality rate
研究概览
简要总结
The ICU mortality rate of patients with septic shock was still high upto 54.1%.In first 6 hours of resuscitation, the goals of resuscitation in sepsis shock after adequate fluid resuscitation is MAP ≥65 mmHg. In refractory septic shock patient, prolong shock correlate with poor outcome due to multiple organ failure. Alternative vasopressor in septic shock with catecholamine resistance has been studied such as terlipressin, methylene blue
- Terlipressin (TP) mediate vasoconstriction via V1 receptors coupled to phospholipase C, and increases intracellular Ca2+ concentration
- Methylene blue (MB) directly inhibits nitric oxide synthase (NOS) by inhibit the enzyme guanylate cyclase (GC)
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 (Participant)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >15 years old
- •Diagnosis septic shock as SCCM/ACCP
- •Refractory septic shock defined as hypotension although adequate fluid resuscitate and high dose vasopressor(NE >0.5 mcg/kg/min)
- •Concent form
排除标准
- •Known case G6PD deficiency
- •Acute respiratory distress syndrome (ARDS)
- •Hx of drug allergy MB, NE, terlipressin
- •Hx of Raynaud's phenomenon, systemic sclerosis, PHT
- •Known case coronary heart disease without treatment
- •Current drug use serotonin reuptake inhibitors (SSRI), Serotonin and norepinephrine reuptake inhibitors (SNRIs)
- •Reject to join project
研究组 & 干预措施
B
after defined refractory shock (adequate fluid resuscitation + add NE>0.5 mcg/kg/min) add Methylene blue 1 mg/kg iv drip then 2 hr later drip 0.5 mg/kg/hr*4 hr (intervention add on to standard care)
干预措施: Methylene Blue (Drug)
C
after defined refractory shock (adequate fluid resuscitation + add NE>0.5 mcg/kg/min) add terlipressin 1 mg IV then repeated dose 20 min later if unstable BP (intervention add on to standard care)
干预措施: Terlipressin (Drug)
结局指标
主要结局
mortality rate
时间窗: 7 days
ICU duration
时间窗: through out off indication need ICU care, an average of 7 days
time to wean of vasopressor
时间窗: through complete weaning off vasopressor, an average of 24 hours
次要结局
- hemodynamic parameter: lactate (mmol/l)(every 2 hr until 6 hr then every 4 hr until wean off vasopressor up to 24 hours)
- hemodynamic parameter: Mean arterial pressure (mmHg)(every 30 min after start protocol up to 6 hr then every 1 hr up to 24 hours)
- hemodynamic parameter: urine output (ml)(every 2 hr until wean off vasopressor up to 24 hours)
研究者
munthana sundusadee
fellowship in department of pulmonary and critical care department
Ramathibodi Hospital