Variation in Natremia Using Two Different Maintenance Intravenous Fluids in Postsurgical Hospitalized Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Change in Sodium Levels
研究概览
简要总结
The primary objective of this study is to compare the blood sodium level after 12 hours following the initiation of therapy with either 0.3% NaCl/dextrose 5% or 0.45% NaCl/dextrose 5%, in postsurgical hospitalized children requiring maintenance IV fluid administration.
详细描述
Background: Despite prescription of maintenance IV fluids in hospitalized children is widely used since 1957 (Holiday & Segar), it is not always adequate for children with acute diseases, leading to hyponatremia. This mainly occurs due to a non-physiologic ADH secretion in this group of patients due to nausea, stress, pain, and surgical interventions, and the use of hypotonic maintenance IV fluids.
0.3% NaCl/dextrose 5%, is widely use as IV maintenance fluid in children after surgery. There is evidence suggesting that these IV fluids used in postsurgical hospitalized patients do not provide the adequate amount of sodium they require, leading to an increased risk of developing hyponatremia. Using 0.45% NaCl/dextrose 5% as IV maintenance fluid in these children would prevent hyponatremia, but this treatment has not been totally studied yet.
Study procedures: Hospitalized children who fulfill inclusion criteria and not having any of the exclusion criteria will be considered for the enrolment after written informed consent.
Venous blood samples will be taken at enrollment (baseline) for estimation of serum sodium. After randomization, one group will receive 0.3% NaCl/dextrose 5%, IV, at standard maintenance rate (100 ml/kg for the first 10 kg of body weight, 50 ml/kg for the next 10 kg, and 20 ml/kg for body weight exceeding 20 kg). The second group will receive 0.45% NaCl/dextrose 5%, IV, at the same rate.
Serum sodium will be estimated in both groups after 12 hours of intravenous fluid therapy.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Month 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Postsurgical children admitted to HGNPE Department of Surgery between january 2010 and october
- •Aged 1 month to 16 years. Initial plasma Na between 135-145 mmol/L. Primary route of fluid administration is anticipated to be intravenous, in the first 12 hours following surgery.
- •Informed consent of parent/guardian.
排除标准
- •• Children with illness that have primary fluid and electrolyte imbalance such as:
- •Shock: Defined as acute circulatory failure resulting in decreased tissue perfusion and manifesting as altered sensorium, hypothermia (<35oC), tachycardia, prolonged capillary filling time (>3 seconds), hypotension (BP < 5th percentile for age), oliguria (<0.5 ml/kg/hr), hypoxemia, hyperlactatemia, requirement of fluid bolus and/ or vasopressors.
- •Diarrhea and Dehydration: Children presenting with diarrhea and features of dehydration: lethargy, irritability and altered sensorium, thirst, decreased urine output, sunken eyes & dry mucous membranes, loss of skin elasticity.; children with ongoing diarrhea will be excluded even if there is no dehydration.
- •Fluid Overload: Cirrhosis, Congestive heart failure, Acute and Chronic renal failure, Nephrotic syndrome.
- •Hyperglycemia: blood glucose > 180 mg/ dl.
- •Require ICU admission.
- •Severe Protein Energy Malnutrition: Defined as grade III (50-59% of expected weight for age) and grade IV (less than 50% of expected weight for age) as per IAP classification.
- •Patients in whom either hypotonic or isotonic solutions may be contraindicated/necessary: i.e. specific neurosurgical patients (ie those at risk of increased ICP, e.g. requiring actual brain surgery, ICP monitor or external ventricular drain insertion), patients with diabetic ketoacidosis, acute (≤ 7 days) burns, pre-existing CHF, liver failure or cirrhosis, renal failure.
- •Patients with known pre-existing risk of PNa derangements: DI or SIADH
研究组 & 干预措施
half saline
Subjects in this arm will receive 0.45% NaCl/dextrose 5% intravenous (IV) maintenance fluids.
干预措施: 0.45% NaCl/dextrose 5% (Drug)
third saline
Subjects in this arm will receive 0.3% NaCl/dextrose 5% intravenous (IV) maintenance fluids.
干预措施: 0.3% NaCl/dextrose 5% (Drug)
结局指标
主要结局
Change in Sodium Levels
时间窗: Change from baseline in sodium level after 12 hours
次要结局
- IV Fluid Intake(12 hours from baseline)