Clinical Efficacy of Indomethacin in Early Treatment of Acute Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Systemic inflammatory response syndrome(SIRS) score at 72 hours after the initial intervention.
研究概览
简要总结
Acute pancreatitis is a common critical disease of the digestive system. Accumulated data showed that overexpression of cyclooxygenase-2 (COX-2) in acute pancreatitis and experimental pancreatitis could be attenuated with COX-2 inhibitors. In recent years, it has been found that timely administration of indomethacin or diclofenac sodium to anus after ERCP can significantly reduce the incidence of AP after ERCP in patients at high risk of AP. The aim of this study was to evaluate the efficacy of rectal indomethacin in reducing the systemic inflammatory response syndrome (SIRS) score in AP patients.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(i) either gender aged 18-70 years; (ii) a confirmed diagnosis of AP; (iii) the time interval from the onset of symptoms to admission was no more than 48 h; (iv) written informed consent was obtained from the patients or their legal representatives.
排除标准
- •(i) pregnancy and breast feeding mother; (ii) severe chronic diseases such as cardiac dysfunction, chronic obstructive pulmonary disease, renal insufficiency, cirrhosis, inflammatory bowel diseases, and malignancies; (iii) peptic ulcer; (iv) pancreatitis due to trauma; (v) drug allergy; (vi) drug abuse and psychosis.
研究组 & 干预措施
convention
patients in convention arm receive conventional management according to AP guidelines of International Association of Pancreatology and the Chinese Society of Gastroenterology, including goal-directed fluid resuscitation, oxygen supply even mechanical ventilation, and nutritional support if necessary.
干预措施: conventional treatment (Other)
convention + indometacin
Besides the conventional treatment,patients in convention + indometacin arm receive 50-mg indomethacin suppositories at intervals of 12 hours for a total of 6 doses.
干预措施: Indometacin (Drug)
convention + indometacin
Besides the conventional treatment,patients in convention + indometacin arm receive 50-mg indomethacin suppositories at intervals of 12 hours for a total of 6 doses.
干预措施: conventional treatment (Other)
结局指标
主要结局
Systemic inflammatory response syndrome(SIRS) score at 72 hours after the initial intervention.
时间窗: 72 hours after the initial intervention.
The minimum value of SIRS is 0, and the maximum value of SIRS is 4. The higher score means a worse outcome.
次要结局
- the serum levels of C-reactive protein(CRP)(72 hours after the initial intervention.)
- the serum levels of interleukin-6(IL-6)(72 hours after the initial intervention.)
- score of abdominal pain(72 hours after the initial intervention.)