An interventional study of Preventive use of advanced antibiotics and Routine in Postoperative Infection, Lactate and Antibiotics, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-27.
Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Prevention
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 297 is above the median of 120 across 4,201 interventional studies indexed under Infections.
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Exclusion Criteria:
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
Treat patients in this group with routine preventive usage of antibiocs: Cefmetazole 1g q12h, in postoperative days 1-3.
Other: Routine
Treat patients in this group with advanced preventive usage of antibiocs: Sulperazon 3g q8h, in postoperative days 1-5.
Also known as: Sulperazon
Treat patients in this group with routine preventive usage of antibiocs: Cefmetazole 1g q12h, in postoperative days 1-3.
Also known as: Cefmetazole
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
Time frame: in 30 days after surgery
The amount of white blood cell
It is expected to be lower in experimental group than in control group
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: postoperative days 1, 3, 5, 7, 14, 21, 28
Plan to share: No
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Peking Union Medical College Hospital