Isotonic Versus Hypotonic Saline for Maintenance Intravenous Fluid Therapy: A Pilot Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- rate of change in serum sodium
研究概览
简要总结
Hyponatremia associated with administration of hypotonic intravenous (IV) fluids may have serious complications. It has recently been suggested that isotonic saline may be a more appropriate choice of maintenance IV fluid. This pilot and feasibility study aims to compare isotonic saline to 0.45% saline in hospitalized children requiring parenteral fluid support in order to:
Aim 1: To determine the feasibility of conducting a double-blind, randomized controlled trial comparing these solutions.
Aim 2a: To compare the rate of change in serum Na (mmol/L/hr) and the incidence of hyponatremia (Na <136 mmol/L) between patients receiving isotonic and hypotonic intravenous fluids at at least 50% of the traditional maintenance rate for an interval of at least 8 hours.
Aim 2b: To compare the incidence of adverse events between the two IV fluid treatment groups.
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
- •1 month to 18 years of age
- •Require IV fluids for at least 8 hr.
- •Baseline serum sodium >=136 mmol/L & <=145 mmol/L
排除标准
- •Baseline serum sodium concentration less than 136 mmol/L or greater than 145 mmol/L
- •Renal disease, a history of cardiac dysfunction or evidence of cardiac dysfunction, pre-existing hypertension, diuretic use, edema, or known adrenal dysfunction
- •Acute neurological illness such as meningitis or encephalitis
- •Severe chronic neurological illnesses (uncontrolled seizure disorders, severe developmental delay)
研究组 & 干预措施
A
0.9% saline in 5% dextrose (intravenous)
干预措施: 0.9% saline in 5% dextrose (intravenous) (Drug)
B
0.45% saline in 5% dextrose (intravenous)
干预措施: 0.45% saline in 5% dextrose (intravenous) (Drug)
结局指标
主要结局
rate of change in serum sodium
时间窗: 8 to 20 hours
次要结局
- hypertension(8 to 20 hours)
- congestive heart failure(8 to 20 hours)
研究者
Bethany Foster
Principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre