Preventive Therapy of Postoperative Intra-abdominal Infection Based on Serum Lactate Changes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Postoperative Infection, Lactate, Antibiotics

Intervention / Treatment
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* Drug: Preventive use of advanced antibiotics
* Other: Routine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preventive use of advanced antibiotics group<br>Treat patients in this group with advanced preventive usage of antibiocs: Sulperazon 3g q8h, in postoperative days 1-5. | Drug: Preventive use of advanced antibiotics<br>* Treat patients in this group with advanced preventive usage of antibiocs: Sulperazon 3g q8h, in postoperative days 1-5.<br>* Other names: Sulperazon;|
| Other: Routine group<br>Treat patients in this group with routine preventive usage of antibiocs: Cefmetazole 1g q12h, in postoperative days 1-3. | Other: Routine<br>* Treat patients in this group with routine preventive usage of antibiocs: Cefmetazole 1g q12h, in postoperative days 1-3.<br>* Other names: Cefmetazole;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of postoperative intra-abdominal infection | The incidence rate of postoperative intra-abdominal infection is expected to be lower in experimental group than control group | in 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of white blood cell | 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 | 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 C-reactive protein | 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 interleukin | 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 tumor necrosis factor α | It is expected to be lower in experimental group than in control group | postoperative days 1, 3, 5, 7, 14, 21, 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Serum lactate, Postoperative intra-abdominal infection, Preventive usage, Advanced antibioties, Strategy