Emergency Department Rapid Intravenous Rehydration (RIVR) for Pediatric Gastroenteritis: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- Rehydration criteria defined by: dehydration score ≤ 1, normal capillary refill time, normal skin turgor, normal respiratory rate
研究概览
简要总结
This study will look at children with dehydration secondary to gastroenteritis requiring IV rehydration and determine whether the proportion rehydrated after two hours is greater in the children who receive rapid intravenous rehydration (RIVR) or in the children who receive standard IV rehydration.
详细描述
Despite a movement toward increased use of enteral rehydration, many children still receive prolonged IV rehydration in the emergency department (ED). These children commonly receive a single IV bolus of normal saline followed by the administration of a hypotonic solution at a maintenance rate.
The mean time spent in the ED by children receiving IV rehydration is significantly longer than the mean time required to treat all other conditions. ED overcrowding has been associated with poor outcomes, prolonged pain and suffering, and dissatisfaction. One of the solutions proposed in the American Academy of Pediatrics Policy Statement on ED overcrowding is that hospitals should strive to improve the efficiency of the care provided. One small step in this direction may be to improve our management of gastroenteritis and dehydration.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 90 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute gastroenteritis as determined by the supervising physician.
- •Age greater than 90 days
- •Dehydrated and unable to consume sufficient oral fluids to overcome their dehydration state
排除标准
- •Weight less than 5 kg or greater than 33 kg
- •Underlying disease which may limit the amount of IV fluids given,including but not limited to: hypoalbuminemic states, renal insufficiency, heart disease requiring pharmacotherapy or lesions that may predispose to congestive heart failure, hypertension, chronic lung disease (excluding asthma), diabetes mellitus, severe anemia, and chronic inflammatory disease
- •Clinical suspicion by the attending physician of myocarditis or previously undiagnosed cardiac or renal disease.
- •History of abdominal surgery or concern regarding an acute surgical abdomen
- •Significant head, chest or abdominal trauma within the preceding 7 days
- •Bilious or bloody vomitus
- •Evidence of hemodynamic compromise (BP < 80 + 2 * age (yrs)) requiring > 20 mL/kg 0.9% normal saline to be administered in the 1st hour
- •Bedside glucose < 2.8 mmol/L (see Section 8.3)
- •Unable to provide a telephone number or unavailable for follow-up
- •Previously enrolled in this trial
研究组 & 干预措施
1
干预措施: Standard IV rehydration (Drug)
2
干预措施: Rapid intravenous rehydration (RIVR) (Drug)
结局指标
主要结局
Rehydration criteria defined by: dehydration score ≤ 1, normal capillary refill time, normal skin turgor, normal respiratory rate
时间窗: 2 hours following the initiation of IV rehydration
次要结局
- Hospitalization(72 hours)
- Repeat ED visit(72 hours)
- Attending physician discharge comfort level(Two and four hours following initiation of IV rehydration)
- Ability to tolerate oral rehydration(Measured per 2 hour time period after consuming 5 mL/kg of liquid)
- Time (in minutes) from initiation of IV rehydration until disposition determination(Determined by outcome)
研究者
Stephen Freedman
Adjunct Scientist
The Hospital for Sick Children