Postoperative Complications After Liver Transplantation

Postoperative Renal, Pulmonary, Cardiovascular Complications and Use of Blood Components in Patients Undergoing Liver Transplantation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02761109

Enrollment

1600

Registered

2016-05-04

Start date

2011-01-31

Completion date

2020-01-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Components Transfusion, Liver Transplantation, Postoperative Cardiovascular Complication, Postoperative Pulmonary Complication, Postoperative Renal Complication

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame	Description
Incidence of renal complication after liver transplantation	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

Secondary

Measure	Time frame	Description
Incidence of cardiovascular complication after liver transplantation	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	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	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

Countries

Italy

Outcome results