- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02761109
Postoperative Complications After Liver Transplantation
Postoperative Renal, Pulmonary, Cardiovascular Complications and Use of Blood Components in Patients Undergoing Liver Transplantation
Incidence and risk factors for renal, cardiovascular and pulmonary complications after liver transplantation are not well defined. Blood products requirement is an important aspect of orthotropic liver transplantation (OLTx) management and has a great impact on patient's outcome. Transfusions of blood products increase perioperative complications and reduce graft and patients survival.
The primary endpoint of the study is to evaluate the incidence of renal complication during ICU stay after liver transplantation using RIFLE criteria; secondary endpoint is to evaluate the incidence of cardiovascular and pulmonary complications. In addition patients' survival and the relationship between blood components use with the development of post-operative complications are evaluated.
Descripción general del estudio
Estado
Descripción detallada
It is conducted a prospective observational cohort study in all Italian liver transplant centers. Adult (> 18 years old) recipients of deceased liver graft between January 2011 and December 2013 were eligible for inclusion. Exclusion criteria were the use of living organ donation, retransplantation, pediatric transplantations, combined transplantation and fulminant hepatic failure.
Investigators collected data using a prospectively maintained computer database managed by the Italian Ministry of Health "Centro Nazionale Trapianti". Anesthetic and perioperative management followed the routine local institution protocols.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Udine, Italia, 33100
- Clinica di Anestesia, rianimazione e terapia intensiva
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- 18 years old or more
Exclusion Criteria:
- Age less than 18 years;
- Liver transplantation living related donor;
- Retransplantation;
- combined transplantation;
- fulminant hepatic failure;
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Incidence of renal complication after liver transplantation
Periodo de tiempo: At 72 post operative hours
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The primary endpoint of the study is to evaluate the incidence of renal complication during ICU stay after liver transplantation using RIFLE criteria
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At 72 post operative hours
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Incidence of cardiovascular complication after liver transplantation
Periodo de tiempo: During ICU length of stay, an average of 4 days.
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To evaluate the incidence of postoperative cardiovascular complications
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During ICU length of stay, an average of 4 days.
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Incidence of pulmonary complication after liver transplantation
Periodo de tiempo: During ICU length of stay, an average of 4 days.
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To evaluate the incidence of postoperative pulmonary complications
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During ICU length of stay, an average of 4 days.
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Number of patients alive after liver transplantation that required blood components transfusion
Periodo de tiempo: At 1 year and at 3 years after liver transplantation
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To investigate the relationship of cardiovascular, pulmonary, renal complications after liver transplantation and the blood components consumption with mortality
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At 1 year and at 3 years after liver transplantation
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Watt KD, Pedersen RA, Kremers WK, Heimbach JK, Charlton MR. Evolution of causes and risk factors for mortality post-liver transplant: results of the NIDDK long-term follow-up study. Am J Transplant. 2010 Jun;10(6):1420-7. doi: 10.1111/j.1600-6143.2010.03126.x. Epub 2010 May 10.
- Barri YM, Sanchez EQ, Jennings LW, Melton LB, Hays S, Levy MF, Klintmalm GB. Acute kidney injury following liver transplantation: definition and outcome. Liver Transpl. 2009 May;15(5):475-83. doi: 10.1002/lt.21682.
- Fouad TR, Abdel-Razek WM, Burak KW, Bain VG, Lee SS. Prediction of cardiac complications after liver transplantation. Transplantation. 2009 Mar 15;87(5):763-70. doi: 10.1097/TP.0b013e318198d734.
- Levesque E, Hoti E, Azoulay D, Honore I, Guignard B, Vibert E, Ichai P, Antoun F, Saliba F, Samuel D. Pulmonary complications after elective liver transplantation-incidence, risk factors, and outcome. Transplantation. 2012 Sep 15;94(5):532-8. doi: 10.1097/TP.0b013e31825c1d41.
- Ramos E, Dalmau A, Sabate A, Lama C, Llado L, Figueras J, Jaurrieta E. Intraoperative red blood cell transfusion in liver transplantation: influence on patient outcome, prediction of requirements, and measures to reduce them. Liver Transpl. 2003 Dec;9(12):1320-7. doi: 10.1016/jlts.2003.50204.
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 (Estimar)
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
Otros números de identificación del estudio
- OLTXCompl
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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