Postoperative InfectionNCT05052619
Preventive Therapy of Postoperative Intra-abdominal Infection Based on Serum Lactate Changes
A study testing Preventive use of advanced antibiotics and Routine in people with Postoperative Infection and Lactate, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Infection, Lactate, Antibiotics
- What is being tested?
- Preventive use of advanced antibiotics and Routine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 297 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Yatong Li, MD, 861069158547, yatongli@qq.com
About this study
Official title: A Prospective, Randomized Clinical Trial to Treat Intra-abdominal Infection Preventively After Pancreatic Surgery Based on Serum Lactate Changes
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.
Read the detailed description
Postoperative intra-abdominal infection is one of the most serious complications after pancreatic resection. Once diagnosed as postoperative intra-abdominal infection, the patient would not only suffer a lot, but also spend much more money and time in hospital. Moreover, subsequent sepsis and septic shock would imperil the patient's life. The preventive use of antibiotics intraoperatively is the key to prevent this complication, but the time, dosage, and choice of the antibiotics are worth discussing. According to the previous work, the investigators found the changes in serum lactate level on postoperative day (POD) 1 could predict postoperative intra-abdominal infection one week before it really happened. The cutoff level of lactate is 3.25mmol/L. Thus, the investigators recommend preventive use of advanced antibiotics for patients who have a peak serum lactate level of >3.250 mmol/L in 24h after pancreatic resection (doi: 10.1007/s00268-021-05987-8. PMID: 33604712).
The investigators would verify the finding in this randomized controlled trial. Patients with peak lactate level >3.250 mmol/L in POD1 and met other inclusion criteria would be recruited and separated into "preventive use of advanced antibiotics group" (experimental group) and "routine group" (control group) randomly. Patients in experimental group would be treated with advanced antibiotics to avoid postoperative intra-abdominal infection. Patients in control group would be treated with routine method (antibiotics with lower levels). To compare the incidence rate of infection and other complications, as well as the payment and other index, the investigators would see if the patients in experimental group could have better prognosis after pancreatic surgery.
- Conditions
- Postoperative Infection, Lactate, Antibiotics
- Being tested
- Preventive use of advanced antibiotics, Routine
- Keywords
- Serum lactate, Postoperative intra-abdominal infection, Preventive usage, Advanced antibioties, Strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventive use of advanced antibioticsDrug
Also called Sulperazon
Treat patients in this group with advanced preventive usage of antibiocs: Sulperazon 3g q8h, in postoperative days 1-5.
RoutineOther
Also called Cefmetazole
Treat patients in this group with routine preventive usage of antibiocs: Cefmetazole 1g q12h, in postoperative days 1-3.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: in 30 days after surgery
Secondary outcomes (5)
The amount of white blood cell
It is expected to be lower in experimental group than in control group
Measured: postoperative days 1, 3, 5, 7, 14, 21, 28
The level of procalcitonin
It is expected to be lower in experimental group than in control group
Measured: postoperative days 1, 3, 5, 7, 14, 21, 28
The level of C-reactive protein
It is expected to be lower in experimental group than in control group
Measured: postoperative days 1, 3, 5, 7, 14, 21, 28
The level of interleukin
It is expected to be lower in experimental group than in control group
Measured: postoperative days 1, 3, 5, 7, 14, 21, 28
The level of tumor necrosis factor α
It is expected to be lower in experimental group than in control group
Measured: postoperative days 1, 3, 5, 7, 14, 21, 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start1 Jul 2021
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative InfectionStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 297 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yatong Li, MD, Study director, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052619
- Sponsor's protocol ID
- Lac-infection
- Status last verified
- Sep 2021
- First submitted
- 12 Sep 2021
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33604712
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Clinical Trial to Treat Intra-abdominal Infection Preventively After Pancreatic Surgery Based on Serum Lactate Changes
- ClinicalTrials.gov ID
- NCT05052619
- Acronym / sponsor ID
- Lac-infection
- Conditions
- Postoperative Infection, Lactate, Antibiotics
- Keywords
- Serum lactate, Postoperative intra-abdominal infection, Preventive usage, Advanced antibioties, Strategy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 297 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 22 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Postoperative intra-abdominal infection is one of the most serious complications after pancreatic resection. Once diagnosed as postoperative intra-abdominal infection, the patient would not only suffer a lot, but also spend much more money and time in hospital. Moreover, subsequent sepsis and septic shock would imperil the patient's life. The preventive use of antibiotics intraoperatively is the key to prevent this complication, but the time, dosage, and choice of the antibiotics are worth discussing. According to the previous work, the investigators found the changes in serum lactate level on postoperative day (POD) 1 could predict postoperative intra-abdominal infection one week before it really happened. The cutoff level of lactate is 3.25mmol/L. Thus, the investigators recommend preventive use of advanced antibiotics for patients who have a peak serum lactate level of >3.250 mmol/L in 24h after pancreatic resection (doi: 10.1007/s00268-021-05987-8. PMID: 33604712).
The investigators would verify the finding in this randomized controlled trial. Patients with peak lactate level >3.250 mmol/L in POD1 and met other inclusion criteria would be recruited and separated into "preventive use of advanced antibiotics group" (experimental group) and "routine group" (control group) randomly. Patients in experimental group would be treated with advanced antibiotics to avoid postoperative intra-abdominal infection. Patients in control group would be treated with routine method (antibiotics with lower levels). To compare the incidence rate of infection and other complications, as well as the payment and other index, the investigators would see if the patients in experimental group could have better prognosis after pancreatic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preventive use of advanced antibiotics group | Experimental | Drug: Preventive use of advanced antibioticsTreat patients in this group with advanced preventive usage of antibiocs: Sulperazon 3g q8h, in postoperative days 1-5. |
| Routine group | Other | Other: RoutineTreat patients in this group with routine preventive usage of antibiocs: Cefmetazole 1g q12h, in postoperative days 1-3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preventive use of advanced antibioticsAlso: SulperazonTreat patients in this group with advanced preventive usage of antibiocs: Sulperazon 3g q8h, in postoperative days 1-5. | Drug | Preventive use of advanced antibiotics group |
| RoutineAlso: CefmetazoleTreat patients in this group with routine preventive usage of antibiocs: Cefmetazole 1g q12h, in postoperative days 1-3. | Other | Routine group |
Primary outcome
Incidence rate of postoperative intra-abdominal infection
Time frame: in 30 days after surgery
The incidence rate of postoperative intra-abdominal infection is expected to be lower in experimental group than control group
5 secondary outcomes
The amount of white blood cell
Time frame: postoperative days 1, 3, 5, 7, 14, 21, 28
The level of procalcitonin
Time frame: postoperative days 1, 3, 5, 7, 14, 21, 28
The level of C-reactive protein
Time frame: postoperative days 1, 3, 5, 7, 14, 21, 28
The level of interleukin
Time frame: postoperative days 1, 3, 5, 7, 14, 21, 28
The level of tumor necrosis factor α
Time frame: postoperative days 1, 3, 5, 7, 14, 21, 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Results publication: PubMed 33604712Li 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.
- Previous work of this RCT: the retrospective studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yatong Li, MD study director
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preventive use of advanced antibiotics and Routine in people with Postoperative Infection and Lactate, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yatong Li, MD (861069158547, yatongli@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of postoperative intra-abdominal infection (time frame: in 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05052619, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.