Postoperative Complications After Liver Transplantation
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|ClinicalTrials.gov Identifier: NCT02761109|
Recruitment Status : Recruiting
First Posted : May 4, 2016
Last Update Posted : October 11, 2018
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.
|Condition or disease|
|Liver Transplantation Postoperative Renal Complication Postoperative Pulmonary Complication Postoperative Cardiovascular Complication Blood Components Transfusion|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1600 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||Postoperative Renal, Pulmonary, Cardiovascular Complications and Use of Blood Components in Patients Undergoing Liver Transplantation|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
- Incidence of renal complication after liver transplantation [ Time Frame: At 72 post operative hours ]The primary endpoint of the study is to evaluate the incidence of renal complication during ICU stay after liver transplantation using RIFLE criteria
- Incidence of cardiovascular complication after liver transplantation [ Time Frame: During ICU length of stay, an average of 4 days. ]To evaluate the incidence of postoperative cardiovascular complications
- Incidence of pulmonary complication after liver transplantation [ Time Frame: During ICU length of stay, an average of 4 days. ]To evaluate the incidence of postoperative pulmonary complications
- Number of patients alive after liver transplantation that required blood components transfusion [ Time Frame: At 1 year and at 3 years after liver transplantation ]To investigate the relationship of cardiovascular, pulmonary, renal complications after liver transplantation and the blood components consumption with mortality
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02761109
|Contact: Della Rocca Giorgio, FPfirstname.lastname@example.org|
|Contact: Pompei Livia, MDemail@example.com|
|Clinica di Anestesia, rianimazione e terapia intensiva||Recruiting|
|Udine, Italy, 33100|
|Contact: Della Rocca Giorgio, FP +390432559501 firstname.lastname@example.org|