Comparison of two different doses of methylene blue as an adjunctive in patients with septic shock: A randomised controlled trial
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Compare the time taken to vasopressor discontinuation after starting of methylene blue
研究概览
简要总结
This prospective, randomized, double-blind, two-arm controlled trial will evaluate the catecholamine-sparing effect of methylene blue (MB) when used as an adjunct to standard vasopressor therapy in adult patients with septic shock. One hundred ICU patients (18-70 years) meeting Sepsis-3 criteria and requiring norepinephrine after adequate resuscitation will be allocated 1:1 to receive either 2 mg/kg IV methylene blue (Group A) or 1 mg/kg IV methylene blue (Group B), each infused over six hours once daily for three consecutive days. All other sepsis management, including vasopressin rescue (initiated if norepinephrine is more than 0.25 µg/kg/min), will follow Surviving Sepsis Campaign guidelines.
The primary outcome is time (hours) to successful discontinuation of norepinephrine, defined as maintenance of mean arterial pressure is more than 65 mmHg for 24 h without vasopressors. Secondary outcomes include total vasopressor duration, MAP and lactate trends over 72 h, vasopressin requirement, adverse events (e.g., hemolysis, serotonin syndrome), ICU length of stay, and 28-day all-cause mortality. Data will be analysed with SPSS v23; p < 0.05 will be considered significant. The study is approved by the IGIMS Institutional Ethics Committee, and written informed consent will be obtained from all participants.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient having body weight
- •70 kg with septic shock as defined by sepsis 3 criteria.
- •highly suspected or confirmed infection, requiring norepinephrine to maintain a mean arterial pressure more than or equal to 65 mmHg and serum lactate more than 2 mmol/L after adequate fluid resuscitation.
排除标准
- •More than 24 hours since initiation of norepinephrine Pregnancy High probability of death within 48 hours Concurrent hemorrhagic, obstructive or hypovolemic shock Refusal of the patient or decision maker to participate Pending damage control surgery Major burn surgery History of glucose 6 phosphate dehydrogenase deficiency Allergy to methylene blue, phenothiazines or food dyes Recent intake (less than 4 weeks) of selective serotonin re-uptake inhibitors.
结局指标
主要结局
Compare the time taken to vasopressor discontinuation after starting of methylene blue
时间窗: From start of methylene blue infusion till day 7
次要结局
- Total duration of vasopressor support(From start of vasopressor administration until cessation)
- Serum lactate clearance(at 24 hour, 48 hour and 72 hour after starting of vasopressors)
- Incidence of vasopressin requirement(At 24hr, 48hr & 72hr after starting the methylene blue till day 7)
- Adverse event such as Hemolysis, Serotonin Syndrome, Cyanosis, Nausea, Vomiting, Arrhythmias(At 24hr, 48hr & 72hr after starting the methylene blue till the day 7)
- ICU length of stay(Time duration for which patients remain in ICU)
- 28 days all cause mortality(Mortality till 28 days after starting of vasopressors)
研究者
Nitin Kumar
Indira Gandhi Institute of Medical Sciences