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临床试验/NCT05052619
NCT05052619招募中不适用

A Prospective, Randomized Clinical Trial to Treat Intra-abdominal Infection Preventively After Pancreatic Surgery Based on Serum Lactate Changes

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 297 人开始时间: 2021年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
297
试验地点
1
主要终点
Incidence rate of postoperative intra-abdominal infection

研究概览

简要总结

Intra-abdominal infection is one of the most serious complications after pancreatic resection. The preventive use of antibiotics intraoperatively could reduce the incidence rate of postoperative intra-abdominal infection. According to the previous retrospective study, changes of serum lactate level on postoperative day1 could predict the incidence rate of postoperative intra-abdominal infection. This prospective RCT is to further validate and promote the findings and conclusion.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Preventive use of advanced antibiotics group

Experimental

Treat patients in this group with advanced preventive usage of antibiocs: Sulperazon 3g q8h, in postoperative days 1-5.

干预措施: Preventive use of advanced antibiotics (Drug)

Routine group

Other

Treat patients in this group with routine preventive usage of antibiocs: Cefmetazole 1g q12h, in postoperative days 1-3.

干预措施: Routine (Other)

结局指标

主要结局

Incidence rate of postoperative intra-abdominal infection

时间窗: in 30 days after surgery

The incidence rate of postoperative intra-abdominal infection is expected to be lower in experimental group than control group

次要结局

  • The level of interleukin(postoperative days 1, 3, 5, 7, 14, 21, 28)
  • The amount of white blood cell(postoperative days 1, 3, 5, 7, 14, 21, 28)
  • The level of procalcitonin(postoperative days 1, 3, 5, 7, 14, 21, 28)
  • The level of C-reactive protein(postoperative days 1, 3, 5, 7, 14, 21, 28)
  • The level of tumor necrosis factor α(postoperative days 1, 3, 5, 7, 14, 21, 28)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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