Preventive use of antibiotics to reduce postoperative infections after pancreatic surgery
A Prospective, Randomized Clinical Trial to Treat Intra-abdominal Infection Preventively After Pancreatic Surgery Based on Serum Lactate Changes
This study is testing if giving antibiotics to patients with high lactate levels after pancreatic surgery can help reduce the risk of infections and improve recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 297 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05052619 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of administering advanced antibiotics to patients undergoing pancreatic resection who exhibit elevated serum lactate levels on the first postoperative day. The study aims to validate previous findings that suggest a correlation between lactate levels and the risk of developing postoperative intra-abdominal infections. Participants will be randomly assigned to either receive preventive antibiotics or standard care, allowing researchers to compare outcomes between the two groups. The goal is to determine if proactive antibiotic treatment can significantly lower infection rates and improve patient recovery.
Who should consider this trial
Good fit: Ideal candidates include patients undergoing pancreatic resection who have a peak serum lactate level greater than 3.250 mmol/L within 24 hours post-surgery.
Not a fit: Patients with a history of upper abdominal surgeries or those who do not meet the lactate criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of serious postoperative infections, leading to better patient outcomes and lower healthcare costs.
How similar studies have performed: Previous studies have indicated a potential link between serum lactate levels and postoperative infections, but this specific preventive approach is being validated for the first time in a randomized controlled setting.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing, Beijing Municipality
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Yatong Li, MD
- Email: yatongli@qq.com
- Phone: 861069158547
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.