Preventive Therapy of Postoperative Intra-abdominal Infection Based on Serum Lactate Changes
Primary Purpose
Postoperative Infection, Lactate, Antibiotics
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Preventive use of advanced antibiotics
Routine
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Infection focused on measuring Serum lactate, Postoperative intra-abdominal infection, Preventive usage, Advanced antibioties, Strategy
Eligibility Criteria
Inclusion Criteria:
- treatment by pancreatic resection, including pancreaticoduodenectomy, pancreatosplenectomy, total pancreatectomy, and other variant operations;
- revival in the intensive care unit (ICU) with standard serum lactate elution treatments after surgery instead of the operation room or general ward;
- availability of complete preoperative, intraoperative, and postoperative data;
- the peak serum lactate level in 24 hours after surgery >3.250 mmol/L.
Exclusion Criteria:
- a history of surgical treatment of any upper abdominal lesions before the current hospital admission;
- the minimum mean arterial pressure <65 mmHg during the operation;
- without written informed consents for the perioperative situation and related studies.
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Preventive use of advanced antibiotics group
Routine group
Arm Description
Treat patients in this group with advanced preventive usage of antibiocs: Sulperazon 3g q8h, in postoperative days 1-5.
Treat patients in this group with routine preventive usage of antibiocs: Cefmetazole 1g q12h, in postoperative days 1-3.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
The amount of white blood cell
It is expected to be lower in experimental group than in control group
The level of procalcitonin
It is expected to be lower in experimental group than in control group
The level of C-reactive protein
It is expected to be lower in experimental group than in control group
The level of interleukin
It is expected to be lower in experimental group than in control group
The level of tumor necrosis factor α
It is expected to be lower in experimental group than in control group
Full Information
NCT ID
NCT05052619
First Posted
September 12, 2021
Last Updated
September 21, 2021
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05052619
Brief Title
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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Infection, Lactate, Antibiotics
Keywords
Serum lactate, Postoperative intra-abdominal infection, Preventive usage, Advanced antibioties, Strategy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
297 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Preventive use of advanced antibiotics group
Arm Type
Experimental
Arm Description
Treat patients in this group with advanced preventive usage of antibiocs: Sulperazon 3g q8h, in postoperative days 1-5.
Arm Title
Routine group
Arm Type
Other
Arm Description
Treat patients in this group with routine preventive usage of antibiocs: Cefmetazole 1g q12h, in postoperative days 1-3.
Intervention Type
Drug
Intervention Name(s)
Preventive use of advanced antibiotics
Other Intervention Name(s)
Sulperazon
Intervention Description
Treat patients in this group with advanced preventive usage of antibiocs: Sulperazon 3g q8h, in postoperative days 1-5.
Intervention Type
Other
Intervention Name(s)
Routine
Other Intervention Name(s)
Cefmetazole
Intervention Description
Treat patients in this group with routine preventive usage of antibiocs: Cefmetazole 1g q12h, in postoperative days 1-3.
Primary Outcome Measure Information:
Title
Incidence rate of postoperative intra-abdominal infection
Description
The incidence rate of postoperative intra-abdominal infection is expected to be lower in experimental group than control group
Time Frame
in 30 days after surgery
Secondary Outcome Measure Information:
Title
The amount of white blood cell
Description
It is expected to be lower in experimental group than in control group
Time Frame
postoperative days 1, 3, 5, 7, 14, 21, 28
Title
The level of procalcitonin
Description
It is expected to be lower in experimental group than in control group
Time Frame
postoperative days 1, 3, 5, 7, 14, 21, 28
Title
The level of C-reactive protein
Description
It is expected to be lower in experimental group than in control group
Time Frame
postoperative days 1, 3, 5, 7, 14, 21, 28
Title
The level of interleukin
Description
It is expected to be lower in experimental group than in control group
Time Frame
postoperative days 1, 3, 5, 7, 14, 21, 28
Title
The level of tumor necrosis factor α
Description
It is expected to be lower in experimental group than in control group
Time Frame
postoperative days 1, 3, 5, 7, 14, 21, 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
treatment by pancreatic resection, including pancreaticoduodenectomy, pancreatosplenectomy, total pancreatectomy, and other variant operations;
revival in the intensive care unit (ICU) with standard serum lactate elution treatments after surgery instead of the operation room or general ward;
availability of complete preoperative, intraoperative, and postoperative data;
the peak serum lactate level in 24 hours after surgery >3.250 mmol/L.
Exclusion Criteria:
a history of surgical treatment of any upper abdominal lesions before the current hospital admission;
the minimum mean arterial pressure <65 mmHg during the operation;
without written informed consents for the perioperative situation and related studies.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yatong Li, MD
Phone
861069158547
Email
yatongli@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yatong Li, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yatong Li, MD
Phone
861069158547
Email
yatongli@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33604712
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.
Results Reference
result
Links:
URL
http://pubmed.ncbi.nlm.nih.gov/33604712/
Description
Previous work of this RCT: the retrospective study
Learn more about this trial
Preventive Therapy of Postoperative Intra-abdominal Infection Based on Serum Lactate Changes
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