A Double-Blind, Randomized, Comparative Efficacy and Safety Trial of Intravenous Solutions for the Treatment of Moderate to Severe Dehydration in Children With Acute Gastroenteritis
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 9
- 主要终点
- Change From Baseline of Venous Serum Bicarbonate at 4 Hours From Start of Intravenous (IV)
研究概览
简要总结
The primary objective of this study is to compare the efficacy and safety of the use of a multiple electrolyte solution to the use of saline for the treatment of moderate to severe dehydration due to acute gastroenteritis (AGE) in children.
详细描述
The primary objective of this study was to compare the efficacy and safety of the use of Plasma Lyte A to the use of NS for the treatment of moderate to severe dehydration and amelioration of metabolic acidosis due to AGE in children (≥ 6 months to < 11 years of age) by measuring serum bicarbonate levels.
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
- 6 Months 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AGE (etiology: viral or other) resulting in presentation to the ED deemed in need of IV rehydration. In the 24 hours prior to presentation, the subject experienced at least 3 episodes of diarrhea (loose and/or watery stools) and/or nonbilious vomiting.
- •Moderate to severe dehydration (as assessed by Gorelick score13 ≥ 4
- •≥ 6 months to < 11 years of age.
- •Healthy except for the underlying etiology of AGE.
- •Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written ICFs and privacy language per national regulations (eg, Health Insurance Portability and Accountability Act [HIPAA], Personal Information Protection and Electronic Documents Act [PIPEDA]) were obtained from the parent/guardian prior to any study-related procedures.
排除标准
- •AGE that did not require IV rehydration per the clinician.
- •Gorelick score ≤ 3
- •Bilious vomiting.
- •Received > 20 mL/kg IV fluid bolus within the 4 hours prior to study enrollment (ie, Hour -4 to Hour 0).
- •Diarrhea lasting > 7 days prior to presentation to the ED.
- •Chronic vomiting disorder.
- •Grossly bloody diarrhea.
- •Chronic diarrheal disorder.
- •Known hyponatremia (sodium < 130 mmol/L [< 130 mEq/L]) within 72 hours prior to enrollment.
- •Known hypernatremia (sodium > 155 mmol/L [> 155 mEq/L]) within 72 hours prior to enrollment.
- •Known hypokalemia (potassium < 3.0 mmol/L [< 3.0 mEq/L]) within 72 hours prior to enrollment.
- •Known hyperkalemia (potassium > 5.5 mmol/L [> 5.5 mEq/L]) within 72 hours prior to enrollment.
- •The use of prohibited medications:
- •Antacids within 24 hours prior to presentation to the ED and during the study.
- •Anti-diarrhea medication within 24 hours prior to presentation to the ED and during the study.
- •The systemic use of corticosteroids/corticotropins was prohibited within 72 hours of enrollment.
- •Chronic health condition affecting the ability to tolerate fluids or those that result in electrolyte abnormalities (eg, chronic renal, cardiac, or pulmonary diagnoses), or abnormalities of sodium or potassium handling (eg, endocrine disorders, medications).
- •Any reason for urgent or emergency hospital admission or ED stays of > 12 hours within 14 days preceding presentation to the ED.
- •Any medical condition likely to interfere with the subject's ability to fully complete all protocol-specified interventions, the ability to undergo all protocol-specified assessments, or likely to prolong the subject's need for medical attention beyond that required for treatment of dehydration.
- •Participation in a study of any investigational drug or device concomitantly or within 30 days prior to enrollment in this study, including previous enrollment in this study.
- •Subject with a > 50% expected chance of dying within 6 months, in the Investigator's opinion.
- •Known hypersensitivity to either of the investigational products.
- •Other serious acute or active conditions that, in the Investigator's opinion, precluded participation in this study.
研究组 & 干预措施
multiple electrolyte solution
Subjects were randomized to receive either multiple electrolyte solution or saline. These solutions were administered IV at 10-20 mL/kg until the subject appeared clinically rehydrated as assessed by the clinician. The selected dose for these solutions is considered standard of care when treating clinical dehydration in children and is consistent with product labeling.
干预措施: multiple electrolyte solution (Drug)
saline
Subjects were randomized to receive either multiple electrolyte solution or saline. These solutions were administered IV at 10-20 mL/kg until the subject appeared clinically rehydrated as assessed by the clinician. The selected dose for these solutions is considered standard of care when treating clinical dehydration in children and is consistent with product labeling.
干预措施: saline (Drug)
结局指标
主要结局
Change From Baseline of Venous Serum Bicarbonate at 4 Hours From Start of Intravenous (IV)
时间窗: Day 1 (4 Hours after start of IV)
The primary efficacy variable was venous serum bicarbonate (marker of metabolic acidosis) at Hour 4 (+/- 1 hour) from the start of the First IV Bolus.
次要结局
未报告次要终点