Postoperative Complications After Liver Transplantation

NCT ID: NCT02761109

Last Updated: 2020-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2020-01-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera S. Maria della Misericordia

OTHER

Sponsor Role lead

Responsible Party

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Giorgio Della Rocca

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinica di Anestesia, rianimazione e terapia intensiva

Udine, , Italy

Site Status

Countries

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Italy

References

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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.1600-6143.2010.03126.x. Epub 2010 May 10.

Reference Type RESULT
PMID: 20486907 (View on PubMed)

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.

Reference Type RESULT
PMID: 19399734 (View on PubMed)

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.

Reference Type RESULT
PMID: 19295324 (View on PubMed)

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. doi: 10.1097/TP.0b013e31825c1d41.

Reference Type RESULT
PMID: 22885879 (View on PubMed)

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):1320-7. doi: 10.1016/jlts.2003.50204.

Reference Type RESULT
PMID: 14625833 (View on PubMed)

Other Identifiers

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OLTXCompl

Identifier Type: -

Identifier Source: org_study_id

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