Postoperative Complications After Liver Transplantation

Completed

• Conditions: Postoperative Renal Complication; Postoperative Pulmonary Complication; Blood Components Transfusion; Liver Transplantation; Postoperative Cardiovascular Complication

• Registration Number: NCT02761109
• Lead Sponsor: Azienda Ospedaliera S. Maria della Misericordia

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2016-04-21
• Study First Submitted QC: 2016-05-02
• Study First Posted: 2016-05-04
• Status Verified: 2020-01
• Primary Completion: 2020-01
• Study Completion: 2020-01
• Last Update Submitted: 2020-01-09
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1600

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Clinica di Anestesia, rianimazione e terapia intensiva; 🇮🇹 Udine, Italy