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Incidence, Risk Factors, Predictors and Survival for Neurological Complications After Liver Transplantation

Sponsor
Institute of Liver and Biliary Sciences, India (Other)
Overall Status
Completed
CT.gov ID
NCT04188717
Collaborator
(none)
253
Enrollment
84
Actual Duration (Months)

Study Details

Study Description

Brief Summary

Liver transplantation is the definitive treatment in patients with chronic liver disease. Neurological complications (NC) occur commonly after liver transplantation. The investigators aim to evaluate the incidence, risk factors and predictors of neurological complications in both living donor and deceased donor transplantation done in the hospital. Between January 2011 to December 2016, 253 liver transplant recipients were recruited for this study. The investigators recorded the incidence of neurological complications, their median time of onset, their relationship with etiology of chronic liver disease, and the risk factors for the complications. The investigators also studied the relationship of neurological complications with duration of hospital and ICU stay, and survival. Using multivariate forward regression analysis , the investigators developed a scoring system for prediction of neurological complications in liver transplantation.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    253 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Incidence, Risk Factors, Predictors and Survival for Neurological Complications After Liver Transplantation- A Retrospective Analysis
    Actual Study Start Date :
    Jan 1, 2010
    Actual Primary Completion Date :
    Dec 31, 2016
    Actual Study Completion Date :
    Jan 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Neurological complications [90 days]

      type of neurological complication

    2. Mortality [90 days]

      mortality due to any cause

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • patients undergoing liver transplant surgery

    • 18-65 years

    Exclusion Criteria:

    • pregnant patients

    • Acute Liver Failure, Acute on Chronic Liver Failure

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Institute of Liver and Biliary Sciences, India

    Investigators

    • Principal Investigator: Karthik T Ponnappan, DM, ILBS

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Institute of Liver and Biliary Sciences, India
    ClinicalTrials.gov Identifier:
    NCT04188717
    Other Study ID Numbers:
    • ILBS - Liver Transplant-2
    First Posted:
    Dec 6, 2019
    Last Update Posted:
    Dec 10, 2019
    Last Verified:
    Nov 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Institute of Liver and Biliary Sciences, India
    liver transplantation
    neurological complications
    postoperative complications
    Additional relevant MeSH terms:
    Postoperative Complications

    Study Results

    No Results Posted as of Dec 10, 2019