Clinical trial NCT05052619: Preventive Therapy of Postoperative Intra-abdominal Infection Based on Serum Lactate Changes
Official title: A Prospective, Randomized Clinical Trial to Treat Intra-abdominal Infection Preventively After Pancreatic Surgery Based on Serum Lactate Changes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Infection
Lactate
Antibiotics
Keywords: Serum lactate
Postoperative intra-abdominal infection
Preventive usage
Advanced antibioties
Strategy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 297
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence rate of postoperative intra-abdominal infection
timeFrame: in 30 days after surgery
Secondary outcomes:
measure: The amount of white blood cell
timeFrame: postoperative days 1, 3, 5, 7, 14, 21, 28
measure: The level of procalcitonin
timeFrame: postoperative days 1, 3, 5, 7, 14, 21, 28
measure: The level of C-reactive protein
timeFrame: postoperative days 1, 3, 5, 7, 14, 21, 28
measure: The level of interleukin
timeFrame: postoperative days 1, 3, 5, 7, 14, 21, 28
measure: The level of tumor necrosis factor α
timeFrame: postoperative days 1, 3, 5, 7, 14, 21, 28
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Yatong Li, MD
role: STUDY_DIRECTOR
References:
citation: 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.