- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05052619
Preventive Therapy of Postoperative Intra-abdominal Infection Based on Serum Lactate Changes
A Prospective, Randomized Clinical Trial to Treat Intra-abdominal Infection Preventively After Pancreatic Surgery Based on Serum Lactate Changes
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yatong Li, MD
- Número de teléfono: 861069158547
- Correo electrónico: yatongli@qq.com
Ubicaciones de estudio
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Beijing
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Beijing, Beijing, Porcelana, 100730
- Reclutamiento
- Peking Union Medical College Hospital
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Contacto:
- Yatong Li, MD
- Número de teléfono: 861069158547
- Correo electrónico: yatongli@qq.com
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
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Treat patients in this group with advanced preventive usage of antibiocs: Sulperazon 3g q8h, in postoperative days 1-5.
Otros nombres:
|
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Otro: Routine group
Treat patients in this group with routine preventive usage of antibiocs: Cefmetazole 1g q12h, in postoperative days 1-3.
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Treat patients in this group with routine preventive usage of antibiocs: Cefmetazole 1g q12h, in postoperative days 1-3.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence rate of postoperative intra-abdominal infection
Periodo de tiempo: in 30 days after surgery
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The incidence rate of postoperative intra-abdominal infection is expected to be lower in experimental group than control group
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in 30 days after surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The amount of white blood cell
Periodo de tiempo: postoperative days 1, 3, 5, 7, 14, 21, 28
|
It is expected to be lower in experimental group than in control group
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postoperative days 1, 3, 5, 7, 14, 21, 28
|
|
The level of procalcitonin
Periodo de tiempo: postoperative days 1, 3, 5, 7, 14, 21, 28
|
It is expected to be lower in experimental group than in control group
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postoperative days 1, 3, 5, 7, 14, 21, 28
|
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The level of C-reactive protein
Periodo de tiempo: postoperative days 1, 3, 5, 7, 14, 21, 28
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It is expected to be lower in experimental group than in control group
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postoperative days 1, 3, 5, 7, 14, 21, 28
|
|
The level of interleukin
Periodo de tiempo: postoperative days 1, 3, 5, 7, 14, 21, 28
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It is expected to be lower in experimental group than in control group
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postoperative days 1, 3, 5, 7, 14, 21, 28
|
|
The level of tumor necrosis factor α
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Yatong Li, MD, Peking Union Medical College Hospital
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Lac-infection
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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