Randomized Multicenter Prospective Clinical Trial to Compare the Effectiveness of Home Care vs Hospital Admission in Patients With Acute Pancreatitis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 225
- 主要终点
- The treatment failure rate
研究概览
简要总结
Acute pancreatitis (AP) is one of the most common reason for hospitalization among gastrointestinal diseases in U.S.. The costs caused by severe AP are higher than mild AP. Nevertheless, approximately 70% of hospital admissions for AP are mild cases, if health cost saving is to be realized, it would be by lowering the cost of managing patients with mild AP without affecting patient's safety and satisfaction.
With the PADI-1 study, where it was possible to confirm the benefits of an early diet, the rapid recovery of patients with mild AP and the reduction of hospital costs, now a new scope is to be given in the treatment of patients with this pathology.
Considering the application of predictive factors of AP severity, and being sure of diagnosing mild AP, a study of home care versus hospitalization for patients with mild AP is proposed. Based on the hypothesis that outpatient care of mild AP patients would be as sage and affective as hospitalization, the aim this study is to campare the results of 3 different strategies of treatment of patients with AP mild. Additionally, satisfaction patient and costs will be analyzed.
详细描述
This is prospective, randomized, controlled, multicentre trial.
OBJECTIVES
Primary objective Compare the results of 3 different strategies for the management of patients with mild acute pancreatitis (AP) and to analyze differences in satisfaction patients and economic costs.
METHODS
Patients with mild AP will be randomly in three groups: group A: outpatient treatment, group B: medical home care and group C: hospitalization.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed of AP by at least two of these three criteria: compatible abdominal pain, amylase or lipase level superior in three-fold respective laboratory baseline levels, and suitable findings in imaging techniques (CT, ultrasound or MRI).
- •age > 18 years, sign consent form.
排除标准
- •pregnant o breastfeeding women.
- •abdominal pain lasting >96 horas before admission.
- •the possibility of poor oral intake for reasons other than AP.
- •Pancreatic neoplasm, endoscopic retrograde cholangiopancreatography or trauma etiology, biliar obstruction.
- •Chronic pancreatitis.
- •Randomization lesser the 24 hours after randomization.
结局指标
主要结局
The treatment failure rate
时间窗: 30 days
Treatment failure is defined as persistence, increase or recurrence of abdominal pain, and or intolerance diet, hospital admission, and mortality
次要结局
- Mortality(30 days)
- Hospital admission(30 days)
- Health costs(30 days)
- Relapse of abdominal pain(30 days)
- Systemic Inflammatory Response Syndrome (SIRS) Score(4 days)
- Number of Participants who Development of Organ Failure(4 days)
- Diet tolerance(30 days)
- Satisfaction medical / hospital care(30 days)
研究者
Elena Ramírez-Maldonado
Principal Investigator
Hospital Universitari Joan XXIII de Tarragona.