RecruitingNot ApplicableNCT05052619

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


Sponsor

Peking Union Medical College Hospital

Enrollment

297 participants

Start Date

Jul 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria3

  • 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.

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Interventions

DRUGPreventive use of advanced antibiotics

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

OTHERRoutine

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


Locations(1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

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NCT05052619


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