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OpenTrials
Completed

NCT Number: NCT02761109

Postoperative Complications After 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinica di Anestesia, rianimazione e terapia intensiva

Udine, 33100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera S. Maria della Misericordia

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2020
Study completion
2020
First posted
May 4, 2016
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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