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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Infection; Antibiotics; Lactate
• Intervention / Treatment: Drug: Preventive use of advanced antibiotics; Other: Routine

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 Type: Interventional
• Enrollment (Anticipated): 297
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yatong Li, MD; Phone Number: 861069158547; Email: yatongli@qq.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Yatong Li, MD; Phone Number: 861069158547; Email: yatongli@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preventive use of advanced antibiotics group; 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 advanced preventive usage of antibiocs: Sulperazon 3g q8h, in postoperative days 1-5.; Other Names: Sulperazon
Other: Routine group; 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 routine preventive usage of antibiocs: Cefmetazole 1g q12h, in postoperative days 1-3.; Other Names: Cefmetazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Director: Yatong Li, MD, Peking Union Medical College Hospital

Publications and helpful links

General Publications

• 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.

Helpful Links

• Previous work of this RCT: the retrospective study

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2026

Study Registration Dates

• First Submitted: September 12, 2021
• First Submitted That Met QC Criteria: September 21, 2021
• First Posted (Actual): September 22, 2021

Study Record Updates

• Last Update Posted (Actual): September 27, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Serum lactate; Strategy; Postoperative intra-abdominal infection; Preventive usage; Advanced antibioties
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Intraabdominal Infections; Anti-Infective Agents; Anti-Infective Agents, Urinary; Renal Agents; Anti-Bacterial Agents; Cefmetazole; Sulperazone
• Other Study ID Numbers: Lac-infection

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No