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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Routine group | Other | Treat patients in this group with routine preventive usage of antibiocs: Cefmetazole 1g q12h, in postoperative days 1-3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preventive use of advanced antibiotics | Drug | Treat patients in this group with advanced preventive usage of antibiocs: Sulperazon 3g q8h, in postoperative days 1-5. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yatong Li, MD | Contact | 861069158547 | yatongli@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Yatong Li, MD | Peking Union Medical College Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33604712 | Result | Li Y, Chen L, Xing C, Ding C, Zhang H, Wang S, Long Y, Guo J, Liao Q, Zhang T, Zhao Y, Dai M. Changes in Serum Lactate Level Predict Postoperative Intra-Abdominal Infection After Pancreatic Resection. World J Surg. 2021 Jun;45(6):1877-1886. doi: 10.1007/s00268-021-05987-8. Epub 2021 Feb 18. |
| Label | URL |
|---|---|
| Previous work of this RCT: the retrospective study | View source |
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| ID | Term |
|---|---|
| C057923 | sulperazone |
| D015311 | Cefmetazole |
| ID | Term |
|---|---|
| D002513 | Cephamycins |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 |
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|
| Routine | Other | Treat patients in this group with routine preventive usage of antibiocs: Cefmetazole 1g q12h, in postoperative days 1-3. |
|
|
| 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 |
| Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |