Preventive Therapy of Postoperative Intra-abdominal Infection Based on Serum Lactate Changes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking Union Medical College Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Preventive use of advanced antibiotics
DrugTreat patients in this group with advanced preventive usage of antibiocs: Sulperazon 3g q8h, in postoperative days 1-5.
Routine
Other interventionTreat patients in this group with routine preventive usage of antibiocs: Cefmetazole 1g q12h, in postoperative days 1-3.
Treatment groups
297 Participants
are divided into 2 treatment groupsGroup A: Preventive use of advanced antibiotics groupExperimental treatment 1 intervention
Group B: Routine groupOther 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
in 30 days after surgerySecondary outcomes
1
The amount of white blood cell
It is expected to be lower in experimental group than in control group
Time frame
postoperative days 1, 3, 5, 7, 14, 21, 282
The level of procalcitonin
It is expected to be lower in experimental group than in control group
Time frame
postoperative days 1, 3, 5, 7, 14, 21, 283
The level of C-reactive protein
It is expected to be lower in experimental group than in control group
Time frame
postoperative days 1, 3, 5, 7, 14, 21, 284
The level of interleukin
It is expected to be lower in experimental group than in control group
Time frame
postoperative days 1, 3, 5, 7, 14, 21, 28Sponsors and contacts
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Source ClinicalTrials.gov