A Randomized Controlled Trial of Home Monitoring Versus Hospitalization in Mild Non-Alcoholic Acute Interstitial Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- The primary outcome of the study was the 30 day hospital readmission rate.
研究概览
简要总结
Acute pancreatitis (AP) is considered a disease requiring in-hospital treatment. We studied the feasibility of home management in AP.The aim of study was to compare 30 day readmission rates in patients with mild non-alcoholic acute pancreatitis (NAAP) randomized to home monitoring versus hospitalization.
详细描述
Between 11/11-5/12, 84 patients with mild NAAP were randomized to home or hospital groups after a short (≤24 hours) hospital stay. AP was defined as ≥2 or more of the following: characteristic abdominal pain, amylase and/or lipase ≥3X the upper limit of normal, and/or imaging findings. Patients with an Imrie's score ≤5 and a harmless acute pancreatitis score (HAPS) ≤2 were included. Patients in both groups received intravenous lactated Ringer for 3 days and pain was treated with intramuscular diclofenac. A nurse visited all patients in the home group on the 2nd, 3rd and 5th day. All patients recalled for follow-up on the 7th, 14th, and 30th days.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosis of AP based on 2 out of 3 findings: characteristic abdominal pain, amylase and/or lipase levels ≥3 times the upper limit of normal, and/or abdominal imaging demonstrating changes of acute pancreatitis
- •Presentation within 48 hours of symptom onset
- •Imrie's scores of ≤5 and HAP score ≤2 within 24 hours of presentation to the hospital
- •Lack of hemoconcentration (hematocrit ≥44%) on presentation since hemoconcentration has been shown to be a risk factor for pancreatic necrosis.
排除标准
- •The presence of organ failure by the Atlanta criteria on the first day of presentation
- •The presence of clinical signs and/or symptoms of sepsis
- •Alcoholic acute pancreatitis
- •A history of abdominal imaging demonstrating a dilated pancreatic duct and/or pancreatic calcifications
- •Coagulopathy (international normalized ratio >1, and/or platelet count <50,000/mm3
- •Comorbidities requiring hospitalization regardless of the presence of AP e.g. acute myocardial infarction, malignancy, cirrhosis, chronic kidney disease, and chronic pulmonary disease)
结局指标
主要结局
The primary outcome of the study was the 30 day hospital readmission rate.
时间窗: 30 days
30 day hospital readmission of home and hospital groups of patients were evaluated.
次要结局
- Other outcomes evaluated included the duration of abdominal pain and time to resumption of an oral diet, both measured in hours from the time of presentation.(hours)
研究者
Ali Tüzün İnce
Asc Prof
Bezmialem Vakif University