Postoperative Complications After Liver Transplantation

Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02761109
• Other study ID #: OLTXCompl
• Status: Completed
• Start date: January 2011
• Est. completion date: January 2020

Study information

• Verified date: January 2020
• Source: Azienda Ospedaliera S. Maria della Misericordia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1600
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Italy	Clinica di Anestesia, rianimazione e terapia intensiva	Udine

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera S. Maria della Misericordia

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Barri YM, Sanchez EQ, Jennings LW, Melton LB, Hays S, Levy MF, Klintmalm GB. Acute kidney injury following liver transplantation: definition and outcome. Liver Transpl. 2009 May;15(5):475-83. doi: 10.1002/lt.21682. — View Citation

Fouad TR, Abdel-Razek WM, Burak KW, Bain VG, Lee SS. Prediction of cardiac complications after liver transplantation. Transplantation. 2009 Mar 15;87(5):763-70. doi: 10.1097/TP.0b013e318198d734. — View Citation

Levesque E, Hoti E, Azoulay D, Honore I, Guignard B, Vibert E, Ichai P, Antoun F, Saliba F, Samuel D. Pulmonary complications after elective liver transplantation-incidence, risk factors, and outcome. Transplantation. 2012 Sep 15;94(5):532-8. — View Citation

Ramos E, Dalmau A, Sabate A, Lama C, Llado L, Figueras J, Jaurrieta E. Intraoperative red blood cell transfusion in liver transplantation: influence on patient outcome, prediction of requirements, and measures to reduce them. Liver Transpl. 2003 Dec;9(12) — View Citation

Watt KD, Pedersen RA, Kremers WK, Heimbach JK, Charlton MR. Evolution of causes and risk factors for mortality post-liver transplant: results of the NIDDK long-term follow-up study. Am J Transplant. 2010 Jun;10(6):1420-7. doi: 10.1111/j.1600-6143.2010.031 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of renal complication after liver transplantation	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	Incidence of cardiovascular complication after liver transplantation	To evaluate the incidence of postoperative cardiovascular complications	During ICU length of stay, an average of 4 days.
Secondary	Incidence of pulmonary complication after liver transplantation	To evaluate the incidence of postoperative pulmonary complications	During ICU length of stay, an average of 4 days.
Secondary	Number of patients alive after liver transplantation that required blood components transfusion	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