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临床试验/NCT03120637
NCT03120637已完成4 期

Evaluating in Cirrhotics With Refractory Vasoplegia the Effect of Methylene Blue in Sepsis: A Randomized Controlled Trial

Institute of Liver and Biliary Sciences, India1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2017年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
111
试验地点
1
主要终点
Survival in both groups

研究概览

简要总结

Mortality rates associated septic shock remains unacceptably high, around 20-50%, with refractory hypotension in half of these patients. Widespread vasodilatation involves the activation of the soluble intracellular enzyme guanylate cyclase (GC) by nitric oxide (NO), resulting in the production of cyclic guanosine monophosphate (cGMP). Initially discovered as an endothelium-derived relaxing factor in blood vessels, NO is made by the enzyme nitric oxide synthase (NOS). It has been suggested that the inhibition of NO generation might be a treatment option for sepsis and septic shock. Methylene blue (MB) is a dye that easily crosses cell membranes, inhibits iNOS, and is capable of inhibiting the GC enzyme in vascular smooth muscle cells.Early use of MB can block the progressive decrease in systemic vascular resistance of patients unresponsive to noradrenaline and mitigate the need for prolonged vasoconstrictor use. The investigators propose to study the effect of methylene blue on cirrhotic adults with sepsis, with refractory vasoplegia unresponsive to maximum doses of noradrenaline and vasopressin.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (>18 years )
  • Refractory septic shock (Noradrenaline >0.5mcg/kg/mt )

排除标准

  • Declined consent
  • Less than 18 years old
  • Immunosuppressant patients (e.g. on steroid medication, active anti-cancer chemotherapeutic agent, etc.)
  • Glucose-6-phosphate dehydrogenase deficiency
  • Medication of Serotonin modulator/SSRI
  • Pre-existing Pulmonary Hypertension
  • CKD-Stage IV/V
  • Patients with GI bleed
  • Patients on DNR
  • Patients declared Brain dead

研究组 & 干预措施

Methylene Blue

Experimental

Methylene Blue intravenous route, 2 mg/kg Loading Dose over 30 minutes, followed by 0.5 mg/kg/hr for 6 hours

干预措施: Methylene Blue (Drug)

结局指标

主要结局

Survival in both groups

时间窗: 2 days

次要结局

  • Systemic Vascular Resistance(6 hours)
  • Mean Arterial Pressure(6 hours)
  • Decrease of vasopressor dose of 20 percent from time of start of test drug.(6 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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