Clinical trial NCT02761109: Postoperative Complications After Liver Transplantation
Official title: Postoperative Renal, Pulmonary, Cardiovascular Complications and Use of Blood Components in Patients Undergoing Liver Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplantation
Postoperative Renal Complication
Postoperative Pulmonary Complication
Postoperative Cardiovascular Complication
Blood Components Transfusion
Lead sponsor: Azienda Ospedaliera S. Maria della Misericordia
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients 18 years old or more undergoing liver transplantation

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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;

Primary outcomes:
measure: Incidence of renal complication after liver transplantation
timeFrame: At 72 post operative hours
Secondary outcomes:
measure: Incidence of cardiovascular complication after liver transplantation
timeFrame: During ICU length of stay, an average of 4 days.
measure: Incidence of pulmonary complication after liver transplantation
timeFrame: During ICU length of stay, an average of 4 days.
measure: Number of patients alive after liver transplantation that required blood components transfusion
timeFrame: At 1 year and at 3 years after liver transplantation
Other outcomes:
Locations:
city: Udine
country: Italy
facility: Clinica di Anestesia, rianimazione e terapia intensiva
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.