Early deresuscitation guided by VExUS vs conventional practice in mechanically ventilated children in PICU a randomised controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- 28-day ventilation free days
研究概览
简要总结
Children aged from 1 year to 12 years admitted to PICU for any reason who are mechanically ventilated and hemodynamically stable (MAP >5th centile and no fluid bolus/escalation of vasoactives for atleast 12 hrs) will be eligible for enrolment. Children with Right Ventricular dysfunction, already on Furosemide, anticipated mechanical ventilation for <48h, AKI KDIGO Stage 3, Severe chronic kidney disease/Cirrhosis/Portal vein thrombosis will be excluded from the study.Enrolled Children will be randomised into either VExUS group or Conventional group. In children being randomised to VExUS group, VExUS Score will be done every 12hours or every 24 hrs (if the initial VExUS score is 0) upto 72 hours of PICU stay. Children with no signs of venous congestion (i.e. VExUS =0) will not be given furosemide infusion and further screening will be done every 24 hrs up to 72 hrs of admission. If VExUS score is 1, continuous infusion of intravenous furosemide at a dose of 0.05mg/kg/hour will be initiated. If VExUS Score is 2 or 3, continuous infusion of intravenous furosemide at a dose of 0.1 mg/kg/hour will be initiated. VExUS score will be performed every 12 hours to monitor for improvement/worsening in venous congestion in children initiated on furosemide infusion. If there is no improvement/worsening in VExUS score at 24 hours of infusion, the infusion dose is doubled. If there is reduction of at least one point in VExUS score at 24 hours after infusion, the furosemide infusion will be continued at the 28 same dose. Frusemide infusion will be discontinued if VExUS score decreased to 0 [for children with initial score of 1 and 2] or 1 [for children with initial score of 3]. In case of the following conditions, Furosemide infusions will be discontinued: Signs of hypoperfusion, Sodium>160mEq/L, metabolic alkalosis(HCo3 >35mEq/L), Severe hypokalemia (<2.5mEq/L).In patients randomised to the Conventional group, based on the clinical assessment and/or fluid overload percentage, the treating team will decide whether to prescribe furosemide or not. As per our unit‘s current practice, Furosemide infusion will be considered at 0.05-0.1mg/kg/hr if fluid overload percentage is high and/or associated clinical evidence of fluid overload. The primary outcome is number of the 28-day ventilation free days. The Secondary outcomes include cumulative fluid overload percentage on day 5 of PICU stay, incidence of new/progressive AKI, oxygenation index until 72 hours after enrolment and organ dysfunction scores until 72 hours after enrolment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Year(s) 至 12.00 Year(s)(—)
- 性别
- All
入选标准
- •Mechanically ventilated and hemodynamically stable without escalation of vasoactives and requirement of fluid bolus in the previous twelve hours.
排除标准
- •Right ventricular dysfunction Already on furosemide therapy Chronic kidney disease cirrhosis portal vein thrombosis Anticipated mechanical ventilation less than two days.
结局指标
主要结局
28-day ventilation free days
时间窗: Number of days free of invasive ventilation from day 0 of randomization till day 28 of randomization | Death or discontinuation of care will be recorded as 0
次要结局
- Cumulative fluid overload percentage(At the end of day 5 of PICU stay)
- Incidence of new/progressive AKI(Till 28 days after randomisation or till discharge from PICU or death, whichever is earlier)
- Oxygenation index until 72 hours after enrolment(Until 72 hours of enrolment)
- Organ dysfunction scores until 72 hours after enrolment(Until 72 hrs of enrolment)
研究者
Prasanna Samynathan
PGIMER: Post Graduate Institute of Medical Education and Research
