Postoperative Complications After Liver Transplantation

January 9, 2020 updated by: Giorgio Della Rocca, Azienda Ospedaliera S. Maria della Misericordia

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Udine, Italy, 33100
        • Clinica di Anestesia, rianimazione e terapia intensiva

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients 18 years old or more undergoing liver transplantation

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At 72 post operative hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During ICU length of stay, an average of 4 days.
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
During ICU length of stay, an average of 4 days.
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
At 1 year and at 3 years after liver transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera S. Maria della Misericordia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

April 21, 2016

First Submitted That Met QC Criteria

May 2, 2016

First Posted (Estimate)

May 4, 2016

Study Record Updates

Last Update Posted (Actual)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 9, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • OLTXCompl

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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