Intravenous Hydration After Surgery Using Boluses of Balanced Salt Solution
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Fluid Adherence to Study Protocol
研究概览
简要总结
Traditional protocols for intravenous fluid administration in children who have undergone a major abdominal or thoracic operation are based on a landmark paper published in 1957 by Holliday and Segar. The basic tenets include: (1) Continuous intravenous fluid administration; (2) Total fluid volume based on the "4:2:1" rule; (3) Use of hypotonic electrolyte solutions, most commonly 0.45% sodium chloride (NaCl) + 20 milliequivalents per liter (mEq/L) potassium chloride (KCl); and (4) Inclusion of 5% dextrose to increase the osmolarity of the infusate and to help prevent ketosis and acidemia.
详细描述
Recent studies have questioned the validity of each of these tenets. Maintenance rate as defined by Holliday & Segar is postulated to be in excess of pediatric patients' post-surgical fluid needs. The investigators propose a novel protocol for the administration of IV fluids to children after major abdominal or thoracic surgery that includes: (1) Intermittent boluses; (2) Total volume administered in 24 hours closer to 2/3 of the traditional maintenance fluid requirements; and (3) Use of a balanced salt solution (Lactated Ringer).
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
- 1 Year 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females age 12 months to 21 years.
- •Weight >= 8 kg.
- •Patients with an uncomplicated abdominal or thoracic surgical procedure in which the expected postoperative length of stay is anticipated to be at least 2-5 days.
- •Patients admitted to a regular bed following surgery.
- •Patients who will be inpatient for approximately 4-8 days postoperatively.
- •Parental/guardian permission (informed consent).
排除标准
- •Patients with a history of diabetes, seizures, hyperglycemia, and hypoglycemia.
- •Patients prescribed insulin.
- •Patients receiving parenteral nutrition.
- •Patients with excessive GI losses (small bowel obstruction, severe diarrhea, large-volume ascites or drainage).
- •Complicated surgery that requires an ICU or ICU transfer immediately after surgery.
- •Patients with any form of hypersensitivity to the study fluids.
- •Laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary, or renal disease:
- •Serum Sodium <130 or >145 mmol/L
- •Serum Potassium <3.0 or >5.0 mEq/L
- •Serum Chloride <90 or >110 mEq/L
- •Serum Creatinine ≥ 1.6 mg/dL
- •Serum Glucose <60 or >180 mg/dL
- •Alanine Aminotransferase >200 U/L
- •Total Bilirubin >12.0 mg/dL
- •Pregnant or lactating females.
- •Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
结局指标
主要结局
Fluid Adherence to Study Protocol
时间窗: 4 Days
Feasibility will be determined if 85% of enrolled study participants receive at least 75% of the expected study fluid in accordance to study protocol.
Feasibility of Measuring and Collecting Urine Output
时间窗: 4 Days
Feasibility will be determined if at least 90% of enrolled study participants have accurate urine collection and urine measurements during the study treatment phase.
次要结局
- Feasibility of Study Laboratory Tests - CMP, d-Stick, Urinalysis(4 Days)
- Feasibility of Randomization(Baseline)