Changes in Serum Lactate Level Predict Postoperative Intra-Abdominal Infection After Pancreatic Resection.
Yatong Li, Lixin Chen, Cheng Xing...
https://pubmed.ncbi.nlm.nih.gov/33604712Actively Recruiting
Led by Peking Union Medical College Hospital · Updated on 2021-09-27
297
Participants Needed
1
Research Sites
156 weeks
Total Duration
Postoperative intra-abdominal infection is a serious complication following pancreatic surgery, which can lead to significant suffering, longer hospital stays, and potentially life-threatening conditions like sepsis. Researchers are studying whether preventive use of antibiotics during surgery, guided by serum lactate level changes on the first day after surgery, can reduce the rate of these infections. This study aims to confirm previous findings that a peak serum lactate level above 3.25 mmol/L within 24 hours after surgery predicts infection risk. Participants with a peak serum lactate level over 3.25 mmol/L on postoperative day one will be randomly assigned to one of two groups. One group receives advanced antibiotics (Sulperazon 3g every 8 hours) for five days after surgery, while the other group receives routine antibiotics (Cefmetazole 1g every 12 hours) for three days. This randomized controlled trial compares infection rates and other outcomes between these two preventive antibiotic strategies. During the study, researchers will monitor participants for 30 days after surgery, assessing the incidence of intra-abdominal infection as the primary outcome. Additional blood tests will track white blood cell counts, procalcitonin, C-reactive protein, interleukin, and tumor necrosis factor alpha levels at multiple points up to 28 days post-surgery. The study also evaluates complications, hospital costs, and overall recovery to determine if advanced antibiotics improve patient outcomes after pancreatic resection.
CONDITIONS
Preventive Therapy of Postoperative Intra-abdominal Infection Based on Serum Lactate Changes
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 1 day
Participants undergo pancreatic surgery and receive initial post-operative care including serum lactate measurement within 24 hours after surgery.
1 hospital stay visit
Duration - 3 to 5 days
Participants receive preventive antibiotic treatment based on their assigned group to reduce risk of postoperative intra-abdominal infection.
Daily visits during postoperative days 1 to 5
Duration - 4 weeks
Participants are monitored for signs of infection and other complications with blood tests on postoperative days 1, 3, 5, 7, 14, 21, and 28.
7 follow-up visits on postoperative days 1, 3, 5, 7, 14, 21, and 28
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Y
Yatong Li, MD
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Yatong Li, Lixin Chen, Cheng Xing...
https://pubmed.ncbi.nlm.nih.gov/33604712