Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05052619

A Prospective, Randomized Clinical Trial to Prevent Intra-abdominal Infection After Pancreatic Surgery Using Serum Lactate Levels

Led by Peking Union Medical College Hospital · Updated on 2021-09-27

297

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Undergoing pancreatic resection, including pancreaticoduodenectomy, pancreatosplenectomy, total pancreatectomy, or similar surgeries
  • Recovering in the intensive care unit (ICU) after surgery with standard serum lactate treatments
  • Have complete preoperative, intraoperative, and postoperative medical data available
  • Peak serum lactate level higher than 3.250 mmol/L within 24 hours after surgery
Not Eligible

You will not qualify if you...

  • Previous surgical treatment of any upper abdominal lesions before current hospital admission
  • Minimum mean arterial pressure below 65 mmHg during the operation
  • Lack of written informed consent for perioperative care and related studies

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Surgery and Immediate Post-operative Care

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

Treatment

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

Post-operative Follow-up

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

Trial Site Locations

Total: 1 location

1

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100730

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Research Team

Y

Yatong Li, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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