A Randomized-controlled Trial of a Targeted Approach to Fluid Resuscitation in Acute Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Prevalence (point prevalence) of the systemic inflammatory response syndrome (SIRS) at 24 hours
研究概览
简要总结
Vigorous fluid resuscitation is currently believed to play a key role in reducing complications associated with acute pancreatitis. However, aggressive fluid replacement can be associated with complications such as pulmonary fluid sequestration. The purpose of this study is to evaluate alternative approaches to early fluid resuscitation for patients with acute pancreatitis.
详细描述
Primary Aim: Evaluate the impact of a goal-directed fluid resuscitation protocol compared to standard fluid resuscitation on systemic inflammation in patients with acute pancreatitis.
Secondary Aim: Evaluate the impact of resuscitation with Lactated Ringer's compared to normal saline on systemic inflammation in acute pancreatitis.
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
- •acute pancreatitis diagnosed by at least 2 criteria
- •adult patients at least 18 years of age
排除标准
- •history of severe cardiovascular, respiratory, renal, hepatic or hematologic/immunologic disease
- •concurrent metabolic or physiologic derangement requiring specific fluid management
- •pregnancy
- •patients transferred from acute care hospital
研究组 & 干预措施
1
Goal-directed fluid resuscitation with lactated Ringer's solution
干预措施: Goal-directed fluid resuscitation (Other)
2
Goal-directed fluid resuscitation with normal saline
干预措施: Goal-directed fluid resuscitation (Other)
3
Standard fluid resuscitation with lactated Ringer's solution
4
Standard fluid resuscitation with normal saline
结局指标
主要结局
Prevalence (point prevalence) of the systemic inflammatory response syndrome (SIRS) at 24 hours
时间窗: first 24 hours of hospitalization
次要结局
未报告次要终点
研究者
Bechien Wu, MD, MPH
Bechien Wu, M.D., M.P.H.
Brigham and Women's Hospital