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

21. september 2021 opdateret af: Peking Union Medical College Hospital

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

297

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Beijing
      • Beijing, Beijing, Kina, 100730
        • Rekruttering
        • Peking Union Medical College Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Preventive use of advanced antibiotics group
Treat patients in this group with advanced preventive usage of antibiocs: Sulperazon 3g q8h, in postoperative days 1-5.
Medicin: Preventive use of advanced antibiotics
Treat patients in this group with advanced preventive usage of antibiocs: Sulperazon 3g q8h, in postoperative days 1-5.
Andre navne:
  • Sulperazon
Andet: Routine group
Treat patients in this group with routine preventive usage of antibiocs: Cefmetazole 1g q12h, in postoperative days 1-3.
Andet: Routine
Treat patients in this group with routine preventive usage of antibiocs: Cefmetazole 1g q12h, in postoperative days 1-3.
Andre navne:
  • Cefmetazole

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence rate of postoperative intra-abdominal infection
Tidsramme: in 30 days after surgery
The incidence rate of postoperative intra-abdominal infection is expected to be lower in experimental group than control group
in 30 days after surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The amount of white blood cell
Tidsramme: postoperative days 1, 3, 5, 7, 14, 21, 28
It is expected to be lower in experimental group than in control group
postoperative days 1, 3, 5, 7, 14, 21, 28
The level of procalcitonin
Tidsramme: postoperative days 1, 3, 5, 7, 14, 21, 28
It is expected to be lower in experimental group than in control group
postoperative days 1, 3, 5, 7, 14, 21, 28
The level of C-reactive protein
Tidsramme: postoperative days 1, 3, 5, 7, 14, 21, 28
It is expected to be lower in experimental group than in control group
postoperative days 1, 3, 5, 7, 14, 21, 28
The level of interleukin
Tidsramme: postoperative days 1, 3, 5, 7, 14, 21, 28
It is expected to be lower in experimental group than in control group
postoperative days 1, 3, 5, 7, 14, 21, 28
The level of tumor necrosis factor α
Tidsramme: postoperative days 1, 3, 5, 7, 14, 21, 28
It is expected to be lower in experimental group than in control group
postoperative days 1, 3, 5, 7, 14, 21, 28

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Peking Union Medical College Hospital

Efterforskere

  • Studieleder: Yatong Li, MD, Peking Union Medical College Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juli 2021

Primær færdiggørelse (Forventet)

1. juli 2023

Studieafslutning (Forventet)

1. juli 2026

Datoer for studieregistrering

Først indsendt

12. september 2021

Først indsendt, der opfyldte QC-kriterier

21. september 2021

Først opslået (Faktiske)

22. september 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. september 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. september 2021

Sidst verificeret

1. september 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Lac-infection

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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Kliniske forsøg med Postoperativ infektion

Kliniske forsøg med Preventive use of advanced antibiotics

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