Association of Intraoperative Renal Regional Oxygen Saturation and Acute Kidney Injury
Association of Intraoperative Renal Regional Oxygen Saturation and Acute Kidney Injury After Living Donor Liver Transplantation
This study is a prospective observational study of a single cohort of the patients who will undergo a scheduled living donor liver transplantation.
The investigators attempt to evaluate the association of intraoperative renal regional oxygen saturation and acute kidney injury in patients undergoing living donor liver transplantation. Near-infrared spectroscopy sensor will be attached to the skin near bilateral kidney areas in all patients and renal regional oxygen saturation will be monitored during the operation. Renal regional oxygen saturation (rSO2) of the patients who developed acute kidney injury postoperatively will be compared with rSO2 of the patients who did not.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Acute kidney injury is a frequent complication after liver transplantation, which is related to poor prognosis and longer hospital stay. There is no sensitive or specific marker for predicting postoperative acute kidney injury, although studies of the biomarkers have shown promising results.
Near-infrared spectroscopy is a non-invasive and real-time monitoring device for regional oxygen saturation measurement. Previous studies revealed that it could be applied to the skin near the kidney and be used to monitor renal regional oxygen saturation.
Therefore, in this study, the investigators will apply near-infrared spectroscopy around kidney area to measure real-time renal regional oxygen saturation during liver transplantation surgery and investigate the association between the intraoperative renal regional oxygen saturation and the development of post-transplant acute kidney injury.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Seoul, Corea, república de, 03080
- Seoul National University Hospital
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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:
- Adult patients scheduled to undergo elective living donor liver transplantation
- Patients who provided written informed consent
Exclusion Criteria:
- Missing preoperative serum creatinine value
- Underlying kidney disease, such as hepatorenal syndrome, chronic kidney disease
- History of unilateral or bilateral nephrectomy
- Patients who died within 48 hours immediately after surgery
- Any skin problem at the attachment site of regional oxygen saturation probe
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: Regional oxygen saturation group
Near-infrared spectroscopy application to the skin near the kidney
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Regional oxygen saturation probe is applied to the skin near the kidney bilaterally and is connected to the regional oxygen saturation monitor.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Acute Kidney Injury
Periodo de tiempo: Within 7 days after surgery
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Acute kidney injury defined by the Kidney Disease Improving Global Outcomes (KDIGO) criteria using postoperative serum creatinine
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Within 7 days after surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Length of hospital stay
Periodo de tiempo: Within 30 days after surgery
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Length of hospital stay
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Within 30 days after surgery
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Nadir oxygen delivery during the surgery
Periodo de tiempo: Within average 8 hours after anesthesia induction during the transplantation surgery
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Nadir oxygen delivery calculated by the cardiac output and arterial oxygen content
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Within average 8 hours after anesthesia induction during the transplantation surgery
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Area under the curve of oxygen delivery during the surgery
Periodo de tiempo: Within average 8 hours after anesthesia induction during the transplantation surgery
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Area under the curve of oxygen delivery calculated by the cardiac output and arterial oxygen content
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Within average 8 hours after anesthesia induction during the transplantation surgery
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Early allograft dysfunction
Periodo de tiempo: on the postoperative 7th day after liver transplantation
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Early allograft dysfunction diagnosed by one or more of the following variables: (1) bilirubin > 10 mg/dL on postoperative day 7; (2) prothrombin time: international normalized ratio > 1.6 on postoperative day 7; (3) aminotransferase level (alanine aminotransferase or aspartate aminotransferase > 2000 IU/ml within the first 7 postoperative days.
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on the postoperative 7th day after liver transplantation
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In-hospital mortality
Periodo de tiempo: Within 30 days after surgery
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In-hospital mortality
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Within 30 days after surgery
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Won Ho Kim, Kim, Seoul National University Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- 1901-087-100
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.
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