Randomized, Double Blind, Controlled Trial of 0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Hospitalized Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Plasma urea, creatinine, glucose and electrolyte levels
研究概览
简要总结
The primary objective of this study is to compare the mean serum sodium at 48 hours following the initiation of therapy with either 0.45% NaCl/dextrose 5% or 0.9% NaCl/dextrose 5%, in children requiring maintenance IV fluid administration.
详细描述
Hyponatremia, has become increasingly recognized as a cause of morbidity and mortality in hospitalized children. The main etiology of hyponatremia in these children has been attributed to the use of hypotonic maintenance IV fluids. The practice of providing IV solutions containing 20-30 mmol/L of Na is based on "physiological needs" proposed by Holliday and Segarin 1957, derived from studies of 61 adults and children. The presence of non-physiologic ADH secretion in the great majority of hospitalized children due to nausea, stress, pain, and surgical interventions, has confirmed that Holliday and Segar's recommendations are frequently inappropriately applied. To avoid the development of hyponatremia, it has been suggested that isotonic 0.9% NaCl/dextrose 5% should be the standard maintenance IV solution.
The routine use of an isotonic maintenance fluid solution has not yet been studied, and concerns exist regarding the potential for hypernatremia and salt and water overload. If isotonic solutions are to be recommended routinely, their overall safety, and specifically the occurrence of dysnatremias and volume overload, should be evaluated in a controlled prospective trial.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 1 month to 18 years
- •Anticipated hospitalization >48 hours
- •Initial plasma Na between 135-145 mmol/L, with a management plan(determined by the responsible physician) to include IV fluids at > 80% of maintenance
- •For children who have had an IV saline bolus, it must have been completed three or more hours prior to having baseline bloods
- •Baseline bloods must be drawn within 3 hours of initial patient contact.
排除标准
- •Diagnosed with, or clinically suspected to have, any of the following: dehydration/gastroenteritis, heart or liver failure, portal hypertension with ascites, metabolic disease, SIADH, diabetes insipidus or mellitus, hypertension, adrenal insufficiency, renal failure [creatinine>100 μmol/L (<3 years); >150 μmol/L (> 3 years)], nephritic or nephrotic syndrome, Kawasaki disease, Sickle cell disease if requiring hyperhydration.
- •Clinically edematous
- •On diuretic medications
- •Plasma glucose is >15 mmol/L
- •Require CCU admission
- •Any patients requiring IV maintenance therapy having conditions/diseases not listed as excluded are eligible to be in this study
研究组 & 干预措施
1
Subjects in this arm will receive hypotonic (0.45% NaCl/5% dextrose) intravenous (IV) maintenance fluids.
干预措施: Hypotonic (0.45% NaCl/5% dextrose) IV maintenance fluids (Drug)
2
Subjects in this arm will receive isotonic (0.9% NaCl/5% dextrose) intravenous (IV) maintenance fluids.
干预措施: Isotonic (0.9% NaCl/5% dextrose) IV maintenance fluids (Drug)
结局指标
主要结局
Plasma urea, creatinine, glucose and electrolyte levels
时间窗: At the time of IV start and every 24 hours thereafter
次要结局
- Oral fluid intake(The duration of the patient's participation in the study)
- Weight(Every 24 hours)
- Standardized clinical assessment of edema(Every 24 hours)
- Blood pressure(Every morning)
研究者
Denis Geary
Nephrologist
The Hospital for Sick Children