Methylene Blue Versus Vasopressin Analogue for Treatment of Septic Shock in Preterm Neonate
试验速览
- 阶段
- 2 期
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- to assess the efficancy of each intervention in improving hemodymaic status: time taken to reach adequate mean blood pressure
研究概览
简要总结
A randomized, prospective study comparing methylene blue versus terlipressin in treatment of catecholamines resistant shock in preterm neonate
详细描述
The study will be an un-blinded, Phase 2, randomized, 1:1, prospective trial comparing methylene blue versus terlipressin in treatment of preterm neonate with catecholamines resistant septic shock the outcome as regard elevation of mean arterial blood pressure will be measured within 72 hours
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of Septic shock according to clinical sepsis score of Tollner and Hematologic Scoring System of Rodwell
- •Refractory septic shock defined as hypotension although adequate fluid resuscitate and high dose vasopressor(NE >0.5 mcg/kg/min)
- •consent form
排除标准
- •known case of G6pd deficiency
- •Hx of drug allergy MB, NE, terlipressin
- •Patients with severely impaired renal function.
- •History of maternal drug intake of selective serotonin reuptake inhibitors,and Serotonin-Norepinephrine Reuptake Inhibitors
研究组 & 干预措施
Methylene Blue group (Group MB)
Methylene Blue is supplied in 1 ml or 10 mL single-dose ampules. Each 1 mL ampule contains 10 mg of methylene blue as a clear dark blue solution
- Any unused product or waste material should be disposed of in accordance with local practice,
- For administration to be diluted before use in a solution of 50 mL 5% Dextrose in Water (D5W) in order to avoid local pain, particularly in the paediatric population. Use the diluted solution immediately after preparation.
- Do not mix with sodium chloride 9 mg/mL (0.9%) solution for injection, because it has been demonstrated that chloride reduces the solubility of methylene blue.
干预措施: Methylene Blue (Drug)
Terlipressin Group (Group TP )
The active substance is terlipressin acetate. Each ampoule contains
1 mg of terlipressin acetate in 8.5 ml solution for injection. This is equivalent to 0.12 mg terlipressin acetate per ml.
- The powder is to be dissolved in the enclosed solvent and slowly administered intravenously. Further dilution up to 10 ml with sterile isotonic sodium chloride solution is possible.
- Store in a refrigerator at 2-8˚C.
- Keep the ampoules in the outer carton in order to protect from light
干预措施: Methylene Blue (Drug)
结局指标
主要结局
to assess the efficancy of each intervention in improving hemodymaic status: time taken to reach adequate mean blood pressure
时间窗: 24hours
The time taken to reach adequate mean blood pressure Reduction in the dosage of the standard inotropic support
次要结局
- to assess the effect of intervention on survival(4 days)
研究者
Rabab Gameel Abd EL hamid allam
Assistant lecturer
Ain Shams University