Impact of protocolized restrictive versus liberal/usual maintenance fluid strategy on fluid overload among mechanically ventilated children: an open-label randomized trial (ReLiSCh-II trial)
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Proportion with fluid overload percentage (FO%) >10%
研究概览
简要总结
Fluid overload of >10% has been shown to be associated with adverse outcomes in mechanically ventilated patients. This study is a randomized, open-label trial comparing the impact of protocolized restrictive versus liberal/usual maintenance fluid strategy on fluid overload among mechanically ventilated children. 130 children (3 months-12 years) who are mechanically ventilated for any indication and have been haemodynamically stable for 6 hours prior to enrollment, with none of the exclusion criteria, will be randomized to receive either "Protocolized restrictive" or "Liberal/Usual" maintenance fluids. Children in the protocolized restrictive group will receive 40-50% maintenance fluids with de-resuscitation with Furosemide infusion if fluid overload percentage (FO%) > 10%; Children in the liberal/usual group will receive 70% maintenance fluids as per unit protocol. The primary outcome will be the proportion with FO% > 10% within 5 days after enrollment. Secondary outcomes will be daily FO% till day 5, inferior vena cava (IVC) diameter and IVC variability index at 48 hours, N-terminal pro-brain natriuretic peptide (NT-proBNP) at 48 hours, safety parameters, ventilator free days and PICU-free days at day 28, and mortality in 28 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 3.00 Month(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •All children between the age group of 3 months to 12 years who are mechanically ventilated (with anticipated mechanical ventilation for ≥48 hours) and have been haemodynamically stable for 6 hours prior to enrolment (no requirement for fluid boluses or increase in vasoactive drugs over the past 6 hours).
排除标准
- •1.Haemodynamically unstable children (requirement of fluid boluses or increase in vasoactive drugs over the past 6 hours) 2.Diarrhoea with dehydration 3.Acute kidney injury 4.Need of renal replacement therapy at admission 5.Known congenital or acquired cardiac disease 6.Chronic liver, lung, or kidney disease 7.Inborn errors of metabolism 8.Diabetic ketoacidosis 9.Known syndrome of inappropriate ADH secretion (SIADH), cerebral salt wasting (CSW) or diabetes insipidus 10.Consent refusal.
结局指标
主要结局
Proportion with fluid overload percentage (FO%) >10%
时间窗: Within first 5 days of enrollment
次要结局
- N-terminal pro-Brain natriuretic peptide (NT-proBNP)(48 hours)
- Daily fluid overload% (FO%) till day 5(Day 1 to Day 5)
- IVC diameter and IVC variability index(48 hours)
- Mortality(Day 28)
- Safety parameters – requirement for fluid boluses, change in fluid prescription, vasoactive agents and daily Vasoactive Inotrope Score (VIS).(Day 1 to Day 5)
- Ventilator Free Days (VFDs)(Day 28)
- PICU Free Days (PFDs)(Day 28)