跳至主要内容
临床试验/CTRI/2016/12/007594
CTRI/2016/12/007594已完成不适用

Balanced Salt Solutions vs. Normal Saline in Children With Septic Shock

AIIMS3 个研究点 分布在 1 个国家目标入组 708 人开始时间: 2017年1月16日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
AIIMS
入组人数
708
试验地点
3
主要终点
Proportion of children with acute kidney injury

研究概览

简要总结

Fluid resuscitation is the cornerstone of pediatric shock management; current practices of fluid resuscitation in children are not evidence based. Normal saline is the preferred crystalloid recommended during initial resuscitation in shock, as the incidence of hyponatremia is lower with normal saline compared to all other fluids available and commonly used.  However, normal saline has its own set of undesired physicochemical actions. Emerging data strongly indicate the increased incidence of hyperchloremia,  metabolic acidosis and consequently, acute kidney injury associated with infusion of large volumes of normal saline. Balanced salt solutions or crystalloids, which have composition resembling plasma but lower chloride concentrations than normal saline, clearly decrease the risk of hypercholremia and metabolic acidosis in adult as well as pediatric studies when used during the peri-operative period. The results favored balanced solutions in comparison to normal saline. However, in the non-surgical setting there is a paucity of evidence on the use of these solutions in children with shock and more evidence needs to be generated to support or refute the use of this fluid as compared to normal saline. Given this background, we decided to compare the two solutions on the incidence of acute kidney injury in the first 7 days in children resuscitated with either of the two fluids. Children receiving volumes of atleast 40 ml/kg in the first hour of resuscitation as boluses would be enrolled and followed up for the proposed outcome variables till death/discharge. We plan to enrol 708 subjects over a period of 3 years. We believe that the proposed study will provide the definitive answer to the optimum crystalloid to be used for fluid resuscitation in children with shock due to hypovolemia or sepsis.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
60.00 Day(s) 至 15.00 Year(s)(—)
性别
All

入选标准

  • Children 2 month to ≤ 15 years with features of shock requiring at least two fluid boluses (20 ml/kg) would be included.

排除标准

  • 1.Children with cardiogenic shock 2.Known patient with chronic kidney disease with baseline deranged renal function (eGFR < 90 ml/1.73 m2/min) 3.Severe malnutrition 4.Children whose parents refuse to give an informed consent.

结局指标

主要结局

Proportion of children with acute kidney injury

时间窗: 1st 7 days after initial fluid resuscitation

次要结局

  • Total fluids received as boluses(In first 6 and 24 hours)
  • Mortality(During ICU stay)
  • Difference in pH, serum bicarbonate and strong ion difference(1. At baseline and 6 hours)
  • Proportion of patients with serum chloride levels 108 meq/L(At 6 and 24 hours)

研究者

发起方
AIIMS
申办方类型
Government medical college

研究点 (3)

Loading locations...

相似试验