Randomized, Controlled, Double Blinded, Clinical Trial: 0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Critically Ill Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Serum Sodium Levels in Both Groups
研究概览
简要总结
The primary objective of this study is to compare the mean serum sodium after 48 hours of therapy with either 0.45% NaCl/dextrose 5% or 0.9% NaCl/dextrose 5%, in critically ill children requiring IV maintenance fluid administration.
详细描述
In patients without possibilities of oral intake, maintenance fluids provide electrolytes and water. Since the original descriptions by Holliday and Segar, the recommended standard maintenance solutions are based on "physiological needs", containing 30-50 mEq/L of sodium.
However hyponatremia has become increasingly recognized in hospitalized children suggesting that Holliday and Segar's recommendations are frequently inappropriately applied.
It has been described augmented intersticial lung water in patients receiving hypotonic maintenance solutions. Also, hyponatremia has been demonstrated in post-surgery critically ill children receiving hypotonic maintenance solutions.
More over, non-physiologic antidiuretic hormone (ADH) secretion has been described in the great majority of hospitalized children due to nausea, stress, pain, and/or surgical interventions.
It has been suggested that isotonic 0.9% NaCl/dextrose 5% should be the standard maintenance intravenous (IV) solution, to avoid the development of hyponatremia.
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
- •Age 1 month to 18 years
- •ICU stay >24 hours
- •Normal seric sodium (135 - 145 mEq/L).
- •Requirement of IV maintenance solutions >80% total fluids intake
排除标准
- •Patients with diagnoses of renal failure (serum creatinine >1 g/dl in <3 years old children, >1,5 in >3 years), hepatic failure with ascitis and portal hypertension, adrenal failure, nephrotic - nephritic syndrome, Kawasaki disease, sickle cell anemia, Syndrome of inappropriate antidiuretic hormone secretion, diabetes insipidus,metabolic disease.
- •Diuretics use in the first 48 hours thereafter indicated IV solutions.
- •Plasma glucose is >200 mg%.
- •Any patients requiring IV fluids therapy different that maintenance (total parenteral nutrition, hyperhydration).
研究组 & 干预措施
Hypotonic
Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids.
干预措施: hypotonic (Drug)
Isotonic
Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids.
干预措施: isotonic (Drug)
结局指标
主要结局
Serum Sodium Levels in Both Groups
时间窗: first 48 hours
Mean serum sodium level of each group will be compared at baseline and in the first 48 hours of IV fluid infusion
次要结局
- Mortality at 28 Days(28 days after admission)
- Mechanical Ventilation Free Days at 28 Day of Admission(first 28 day after starting mechanical ventilation)
- ICU Length of Stay(180 days)