Performance of VExUS with standard of care versus standard of care as guide for decongestive therapy in children with AKI in the age group of 5-18 Years – A Pilot, feasibility randomised control trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- AIIMS BHOPAL
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Renal replacement therapy free days during the initial 28 days in children with Acute Kidney Injury
研究概览
简要总结
Assessment of volume status is critical in all children with Acute kidney injury (AKI). Peripheral signs of fluid overload did not correlate with AKI, which reemphasizes the fact that they might not truly reflect the intravascular volume status. Central venous pressure determination is an invasive procedure and it’s values can be influenced by various factors. Over the past years point of care ultra sound (POCUS) is identified as a non invasive bedside monitor for evaluating venous congestion and this helps to monitor the response to decongestive therapy .Venous excess ultrasound (VExUS) is emerging as a valuable bed side tool to gain real time hemodynamic insights. The present study aimed to establish the usefulness of the VExUS score in children with AKI for detecting systemic venous congestion and directing the decongestive therapy in comparison with current standard of care for AKI in children .To date there is paucity of literature on applicability and usefullnes of VExUS score a an estimator of the degree of venous congestion in pediatric patients. This study will be one of the first in evaluation of performance and utility of VExUS in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 5.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 5 to 18 years with acute kidney injury (AKI) admitted in Pediatric department of AIIMS Bhopal.
排除标准
- •i.All children with who are eligible, whose parents refuse to give written informed consent.
- •ii.Children diagnosed with CKD stage 3 or above.
- •iii.All children who are already diagnosed with chronic liver disease, Budd Chiari syndrome, moderate to severe tricuspid regurgitation, chronic pulmonary hypertension.
- •iv.All children who anatomical abnormality of liver v.All children with renal vascular abnormality, gross hydronephrosis and cystic kidney disease vi.All children who had received RRT prior to hospital admission.
结局指标
主要结局
Renal replacement therapy free days during the initial 28 days in children with Acute Kidney Injury
时间窗: 28 days after diagnosis of AKI in child
Mortality in children with Acute Kidney injury in both groups
时间窗: 28 days after diagnosis of AKI in child
次要结局
- Cumulative fluid overload in both the group at the end day 7 of enrolment(Initial 7 days after diagnosing Acute kidney injury in child)
- To evaluate the occurrence Intradialytic hypotension in children with AKI receiving RRT in both group(Initial 7 days after diagnosing Acute kidney injury in child)
- To evaluate the requirement of total diuretic dose in both groups(Initial 7 days after diagnosing Acute kidney injury in child)
- To evaluate the correlation of VExUS score with need of RRT
- To evaluate the proportion of children with AKI developing dyselectrolytemia (in terms of sodium, potassium and calcium disturbances) in both groups.(Initial 7 days after diagnosing Acute kidney injury in child)