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Postoperative Complications After Liver Transplantation

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ClinicalTrials.gov Identifier: NCT02761109
Recruitment Status : Recruiting
First Posted : May 4, 2016
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Giorgio Della Rocca, 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.


Condition or disease
Liver Transplantation Postoperative Renal Complication Postoperative Pulmonary Complication Postoperative Cardiovascular Complication Blood Components Transfusion

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 [Patient Registry]
Estimated Enrollment : 1600 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Postoperative Renal, Pulmonary, Cardiovascular Complications and Use of Blood Components in Patients Undergoing Liver Transplantation
Study Start Date : January 2011
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients 18 years old or more undergoing liver transplantation
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02761109


Contacts
Contact: Della Rocca Giorgio, FP +390432559501 clinicaanestesiarianimazione@aoud.sanita.fvg.it
Contact: Pompei Livia, MD +390432559501 clinicaanestesiarianimazione@aoud.sanita.fvg.it

Locations
Italy
Clinica di Anestesia, rianimazione e terapia intensiva Recruiting
Udine, Italy, 33100
Contact: Della Rocca Giorgio, FP    +390432559501    clinicaanestesiarianimazione@aoud.sanita.fvg.it   
Sponsors and Collaborators
Azienda Ospedaliera S. Maria della Misericordia

Publications of Results:
Responsible Party: Giorgio Della Rocca, Full Professor, Azienda Ospedaliera S. Maria della Misericordia
ClinicalTrials.gov Identifier: NCT02761109     History of Changes
Other Study ID Numbers: OLTXCompl
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes