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

Not Applicable

Recruiting

• Conditions: Postoperative Infection; Antibiotics; Lactate
• Interventions: Drug: Preventive use of advanced antibiotics; Other: Routine

• Registration Number: NCT05052619
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-07-01
• Status Verified: 2021-09
• Study First Submitted: 2021-09-12
• Study First Submitted QC: 2021-09-21
• Last Update Submitted: 2021-09-21
• Study First Posted: 2021-09-22
• Last Update Posted: 2021-09-27
• Primary Completion: 2023-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 297

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preventive use of advanced antibiotics group	Preventive use of advanced antibiotics	Treat patients in this group with advanced preventive usage of antibiocs: Sulperazon 3g q8h, in postoperative days 1-5.
Routine group	Routine	Treat patients in this group with routine preventive usage of antibiocs: Cefmetazole 1g q12h, in postoperative days 1-3.

Primary Outcome Measures

Name	Time	Method
Incidence rate of postoperative intra-abdominal infection	in 30 days after surgery	The incidence rate of postoperative intra-abdominal infection is expected to be lower in experimental group than control group

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China