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

Antibiotics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05052619
• Other study ID #: Lac-infection
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: July 1, 2026

Study information

• Verified date: September 2021
• Source: Peking Union Medical College Hospital
• Contact: Yatong Li, MD
• Phone: 861069158547
• Email: yatongli[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 297
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. treatment by pancreatic resection, including pancreaticoduodenectomy, pancreatosplenectomy, total pancreatectomy, and other variant operations;

2. revival in the intensive care unit (ICU) with standard serum lactate elution treatments after surgery instead of the operation room or general ward;

3. availability of complete preoperative, intraoperative, and postoperative data;

4. the peak serum lactate level in 24 hours after surgery >3.250 mmol/L.

Exclusion Criteria:

1. a history of surgical treatment of any upper abdominal lesions before the current hospital admission;

2. the minimum mean arterial pressure <65 mmHg during the operation;

3. without written informed consents for the perioperative situation and related studies.

Related Conditions & MeSH terms

• Antibiotics
• Communicable Diseases
• Infections
• Intraabdominal Infections
• Lactate
• Postoperative Infection

Intervention

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

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

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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/s — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	The level of tumor necrosis factor a	It is expected to be lower in experimental group than in control group	postoperative days 1, 3, 5, 7, 14, 21, 28

External Links

•   Previous work of this RCT: the retrospective study