Preventive Therapy of Postoperative Intra-abdominal Infection Based on Serum Lactate Changes
A Prospective, Randomized Clinical Trial to Treat Intra-abdominal Infection Preventively After Pancreatic Surgery Based on Serum Lactate Changes
研究概览
详细说明
Postoperative intra-abdominal infection is one of the most serious complications after pancreatic resection. Once diagnosed as postoperative intra-abdominal infection, the patient would not only suffer a lot, but also spend much more money and time in hospital. Moreover, subsequent sepsis and septic shock would imperil the patient's life. The preventive use of antibiotics intraoperatively is the key to prevent this complication, but the time, dosage, and choice of the antibiotics are worth discussing. According to the previous work, the investigators found the changes in serum lactate level on postoperative day (POD) 1 could predict postoperative intra-abdominal infection one week before it really happened. The cutoff level of lactate is 3.25mmol/L. Thus, the investigators recommend preventive use of advanced antibiotics for patients who have a peak serum lactate level of >3.250 mmol/L in 24h after pancreatic resection (doi: 10.1007/s00268-021-05987-8. PMID: 33604712).
The investigators would verify the finding in this randomized controlled trial. Patients with peak lactate level >3.250 mmol/L in POD1 and met other inclusion criteria would be recruited and separated into "preventive use of advanced antibiotics group" (experimental group) and "routine group" (control group) randomly. Patients in experimental group would be treated with advanced antibiotics to avoid postoperative intra-abdominal infection. Patients in control group would be treated with routine method (antibiotics with lower levels). To compare the incidence rate of infection and other complications, as well as the payment and other index, the investigators would see if the patients in experimental group could have better prognosis after pancreatic surgery.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Yatong Li, MD
- 电话号码:861069158547
- 邮箱:yatongli@qq.com
学习地点
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-
Beijing
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Beijing、Beijing、中国、100730
- 招聘中
- Peking Union Medical College Hospital
-
接触:
- Yatong Li, MD
- 电话号码:861069158547
- 邮箱:yatongli@qq.com
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- treatment by pancreatic resection, including pancreaticoduodenectomy, pancreatosplenectomy, total pancreatectomy, and other variant operations;
- revival in the intensive care unit (ICU) with standard serum lactate elution treatments after surgery instead of the operation room or general ward;
- availability of complete preoperative, intraoperative, and postoperative data;
- the peak serum lactate level in 24 hours after surgery >3.250 mmol/L.
Exclusion Criteria:
- a history of surgical treatment of any upper abdominal lesions before the current hospital admission;
- the minimum mean arterial pressure <65 mmHg during the operation;
- without written informed consents for the perioperative situation and related studies.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Preventive use of advanced antibiotics group
Treat patients in this group with advanced preventive usage of antibiocs: Sulperazon 3g q8h, in postoperative days 1-5.
|
Treat patients in this group with advanced preventive usage of antibiocs: Sulperazon 3g q8h, in postoperative days 1-5.
其他名称:
|
其他:Routine group
Treat patients in this group with routine preventive usage of antibiocs: Cefmetazole 1g q12h, in postoperative days 1-3.
|
Treat patients in this group with routine preventive usage of antibiocs: Cefmetazole 1g q12h, in postoperative days 1-3.
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Incidence rate of postoperative intra-abdominal infection
大体时间:in 30 days after surgery
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The incidence rate of postoperative intra-abdominal infection is expected to be lower in experimental group than control group
|
in 30 days after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
The amount of white blood cell
大体时间:postoperative days 1, 3, 5, 7, 14, 21, 28
|
It is expected to be lower in experimental group than in control group
|
postoperative days 1, 3, 5, 7, 14, 21, 28
|
The level of procalcitonin
大体时间:postoperative days 1, 3, 5, 7, 14, 21, 28
|
It is expected to be lower in experimental group than in control group
|
postoperative days 1, 3, 5, 7, 14, 21, 28
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The level of C-reactive protein
大体时间:postoperative days 1, 3, 5, 7, 14, 21, 28
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It is expected to be lower in experimental group than in control group
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postoperative days 1, 3, 5, 7, 14, 21, 28
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The level of interleukin
大体时间:postoperative days 1, 3, 5, 7, 14, 21, 28
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It is expected to be lower in experimental group than in control group
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postoperative days 1, 3, 5, 7, 14, 21, 28
|
The level of tumor necrosis factor α
大体时间:postoperative days 1, 3, 5, 7, 14, 21, 28
|
It is expected to be lower in experimental group than in control group
|
postoperative days 1, 3, 5, 7, 14, 21, 28
|
合作者和调查者
调查人员
- 研究主任:Yatong Li, MD、Peking Union Medical College Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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