Fluid Therapy in Acutely Ill Children - a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 660
- 试验地点
- 1
- 主要终点
- Proportion of children with a clinically significant electrolyte disorder
研究概览
简要总结
The main objective of the trial is to evaluate the risk of hypokalemia following administration of a isotonic solution compared to a hypotonic solution in acutely ill hospitalised children, who need intravenous fluid therapy.
详细描述
The main objective of the trial is to evaluate the risk of hypokalemia (low plasma potassium concentration) following administration of a Plasmalyte Glucos 50 mg/mL solution compared to a 0.45% saline in 5% dextrose solution in acutely ill hospitalised children, who need intravenous fluid therapy. The secondary objective of the trial is to evaluate the risk of hyponatremia (low plasma sodium concentration) and the risk of hypernatremia (high plasma sodium concentration) following administration of isotonic solution compared to hypotonic solution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Acutely ill hospitalised children
- •Need for intravenous fluid therapy
排除标准
- •An initial plasma sodium concentration of lower than 130 mmol/L
- •An initial plasma sodium concentration of higher than 150 mmol/L
- •An initial plasma potassium concentration of lower than 3.0 mmol/L
- •Need for 10% glucose solution
- •Diabetes insipidus
- •Diabetic ketoacidosis
- •Renal disease that needs dialysis
- •Protocol-determined chemotherapy hydration
- •Severe liver disease
- •Inborn errors of metabolism that need protocol-determined fluid therapy
研究组 & 干预措施
Isotonic solution
Plasmalyte Glucos 50 mg/mL; total daily fluid requirements are estimated using the Holiday-Segar method plus possible dehydration (according to child's weight loss during acute illness); intravenous fluids are administered using delivery pumps programmed for an hourly infusion rate (mL/hour); intravenous fluids are administered as long as needed during hospitalization, but no longer than seven days after admission.
干预措施: Plasmalyte Glucos 50 mg/mL (Drug)
Hypotonic solution
0.45% saline in 5% dextrose; total daily fluid requirements are estimated using the Holiday-Segar method plus possible dehydration (according to child's weight loss during acute illness); intravenous fluids are administered using delivery pumps programmed for an hourly infusion rate (mL/hour); intravenous fluids are administered as long as needed during hospitalization, but no longer than seven days after admission.
干预措施: 0.45% saline in 5% dextrose (Drug)
结局指标
主要结局
Proportion of children with a clinically significant electrolyte disorder
时间窗: Plasma sodium and potassium concentrations are assessed daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days.
Plasma potassium concentration\<3.5 mmol/L, or hypernatremia \>148 mmol/L, or hyponatremia \<132 mmol/L
次要结局
- Proportion of children with hyponatremia(Plasma sodium and potassium concentrations are assessed daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days.)
- Concentration of copeptin in plasma samples(6-24 hours after study entry)
- Proportion of children with hypokalemia(0-7 days from study entry)
- Concentration of bicarbonate (HCO3) in plasma samples(1-3 days after study entry)
- Alkalosis measured by base excess (BE) in blood gas analysis(1-3 days after study entry)
- Proportion of children who needed change of the study fluid treatment(From randomization up to seven days.)
- Proportion of children admitted to ICU(From randomization up to seven days.)
- Time to discharge from hospital in hours(From randomization up to seven days.)
- Proportion of children with hypernatremia(Plasma sodium and potassium concentrations are assessed daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days.)
- Acidosis measured by pH in blood gas analysis(1-3 days after study entry)
- Number of deaths(0-30 days from study entry)
- Proportion of children with severe hypokalemia(0-7 days from study entry)
- Fluid retention (g) measured by the weight change(0-7 days: Body weight is measured daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days.)
- Duration of intravenous fluid therapy(From randomization up to seven days.)
研究者
Terhi Tapiainen
Adjunct professor
University of Oulu