CTRI/2018/10/016169已完成4 期
Superior venacaval oxygen saturation monitoring (Intermittent / Continuous) based Goal Directed Therapy vs Standard Care in Children with Septic Shock: An Open Label Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- PGIMER
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
This study will be conducted in Pediatric emergency and PICU, PGIMER, Chandigarh. Children between 6 months to 12 years of age presenting with septic shock will be randomized into 2 groups: Goal directed therapy group and Standard care group.Goal directed therapy group will be further divided into continuous ScvO2 and intermittent ScvO2 group. GDT group will receive treatment targeting ScvO2>70% including fluids, vasoactive and blood products and Standard care will follow existing unit protocols. Outcome parameters like mortality, duration of stay and vasoactive support will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 6.00 Month(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •All children ≥ 6 month to <12 years AND ii.
- •Presenting to Pediatric ER with clinical septic shock OR iii.
- •Developing it within 24 hours of admission to Pediatric ER Septic shock will be defined by presence of clinically suspected sepsis with cardiovascular organ dysfunction i.e., children with persistent hypotension (MAP <5th centile for age and gender) despite 40 ml/kg of resuscitation fluid and requiring vasoactive drug infusion during first 1 hour.
排除标准
- •Contraindications for central neck venous line insertion (IJV or Subclavian vein) like bleeding tendencies, or not accessible for line insertion due to short neck or local disease.
- •Children already on inotrope with inotrope score of >10 at arrival to our hospital.
- •Children with known or suspected congenital heart disease iv.
- •Immunocompromised patients, e.g., primary immunodeficiency disorders, HIV (exposed or positive), patients with malignancies or other diseases on immunosuppressive medications including steroids.
- •Children with chronic illness like tuberculosis, chronic liver disease, chronic kidney disease, chronic respiratory disease etc.
- •Known Inborn errors of metabolism vii.
- •Children with shock primarily due to diarrhea and severe dehydration.
- •viii.Children with suspected healthcare associated infection.
结局指标
主要结局
Mortality
时间窗: 14 day
次要结局
- To assess the baseline and trend of ScvO2 in the two groups(5 days)
- To compare the time to attainment of end points of shock resuscitation (as defined by BP less than 5th centile MAP for the age and gender, CFT 2 sec, SpO2 70%, and lactate 2 mmol/L)(5 days)
- Inotrope free days in 120 hours in the two groups(5 days)
- Length of Acute Care Area stay(28 days)
- Acute Care Areas free days in 14 days in the two groups(14 days)
- To compare the effect of continuous versus intermittent ScvO2 monitoring on achievement of end points as defined above and mortality.(14 days)
- To study the correlation of ScvO2 with lactate in the two groups.(5 days)
- To compare Organ dysfunction scores (pediatric SOFA and PeLOD) over first 7 days in the two groups(7 days)
- Duration of vasoactive support in the two groups(5 days)
- Length of hospital stay(28 days)
研究者
研究点 (1)
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