Oral Versus Intravenous Fluid Therapy in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 3
- 主要终点
- Percentage of patients achieving the fluid volume prescribed during the first 48 hours in the emergency department
研究概览
简要总结
The goal of this randomized clinical feasibility trial is to determine whether oral fluid therapy can achieve prescribed fluid volumes as effectively as intravenous fluid therapy in adult patients admitted to the emergency department who require fluid treatment.
The main questions it aims to answer are:
Are patients receiving oral fluids equally likely to achieve the prescribed fluid volume compared with patients receiving intravenous fluids?
Is it feasible to conduct a randomized trial of oral versus intravenous fluid therapy in the emergency department, based on recruitment rate and protocol adherence?
Researchers will compare oral tap water administration with standard intravenous crystalloid therapy to assess whether oral fluids are non-inferior in achieving prescribed fluid volumes and to evaluate feasibility outcomes.
Participants will:
Be randomized to receive either oral tap water or intravenous crystalloid fluids during their stay in the emergency department
Receive a fluid volume and administration rate determined by the treating physician
Be monitored according to standard clinical practice during the emergency department stay
Have fluid intake, vital signs, and clinical outcomes recorded, with follow-up through routine health records up to 30 days after inclusion
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or above
- •At least 1000 ml of crystalloid fluid therapy prescribed by the physician
排除标准
- •Altered mental state prohibiting oral fluid intake (Glasgow Coma Scale ≤ 12)
- •Pregnancy
- •Oral fluids contraindicated (e.g. bowel obstruction)
- •Severe hyponatremia (sodium <120 mEq/L)
- •Requiring treatment in the intensive care unit
研究组 & 干预措施
Intravenous fluids
Participants randomized to receive IV crystalloid fluids during ED stay
干预措施: Intravenous fluids (Other)
Oral fluids
Participants randomized to receive oral tap water during ED stay
干预措施: Oral fluids (Other)
结局指标
主要结局
Percentage of patients achieving the fluid volume prescribed during the first 48 hours in the emergency department
时间窗: From inclusion until end of participation. End of participation is defined as the timepoint of leaving the emergency department or after 48 hours, whichever happens first.
次要结局
- Fluids received in the ED (ml)(From inclusion to end of participation (defined as ED stay or maximum of 48 hours), unless mentioned otherwise)
- Fluids received in the ED after inclusion in the study (ml)(From inclusion to end of participation (defined as ED stay or maximum of 48 hours), unless mentioned otherwise)
- Change in systolic and mean arterial pressure at 8 hours or discharge, whatever comes first.(8 hours or discharge, whatever comes first.)
- Hospital-free days alive at 30 days (counting up to the day the patient deceased if applicable)(30 days)
- Mortality at 30 days(30 days)
- Number of hours with a peripheral intravenous catheter(From inclusion to end of participation (defined as ED stay or maximum of 48 hours), unless mentioned otherwise)