NCT05052619

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
297

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Jul 2021Jul 2026

Study Start

First participant enrolled

July 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 22, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

September 27, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

September 12, 2021

Last Update Submit

September 21, 2021

Conditions

Postoperative InfectionLactateAntibiotics

Keywords

Serum lactatePostoperative intra-abdominal infectionPreventive usageAdvanced antibiotiesStrategy

Outcome Measures

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

    in 30 days after surgery

Secondary Outcomes (5)

  • The amount of white blood cell

    postoperative days 1, 3, 5, 7, 14, 21, 28

  • The level of procalcitonin

    postoperative days 1, 3, 5, 7, 14, 21, 28

  • The level of C-reactive protein

    postoperative days 1, 3, 5, 7, 14, 21, 28

  • The level of interleukin

    postoperative days 1, 3, 5, 7, 14, 21, 28

  • The level of tumor necrosis factor α

    postoperative days 1, 3, 5, 7, 14, 21, 28

Study Arms (2)

Preventive use of advanced antibiotics group

EXPERIMENTAL

Treat patients in this group with advanced preventive usage of antibiocs: Sulperazon 3g q8h, in postoperative days 1-5.

Drug: Preventive use of advanced antibiotics

Routine group

OTHER

Treat patients in this group with routine preventive usage of antibiocs: Cefmetazole 1g q12h, in postoperative days 1-3.

Other: Routine

Interventions

Preventive use of advanced antibioticsDRUG

Treat patients in this group with advanced preventive usage of antibiocs: Sulperazon 3g q8h, in postoperative days 1-5.

Also known as: Sulperazon
Preventive use of advanced antibiotics group
RoutineOTHER

Treat patients in this group with routine preventive usage of antibiocs: Cefmetazole 1g q12h, in postoperative days 1-3.

Also known as: Cefmetazole
Routine group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33604712RESULT

Related Links

MeSH Terms

Interventions

sulperazoneCefmetazole

Intervention Hierarchy (Ancestors)

CephamycinsCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Yatong Li, MD

    Peking Union Medical College Hospital

    STUDY DIRECTOR

Central Study Contacts

Yatong Li, MD

CONTACT

861069158547yatongli@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2021

First Posted

September 22, 2021

Study Start

July 1, 2021

Primary Completion

July 1, 2023

Study Completion (Estimated)

July 1, 2026

Last Updated

September 27, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)