Proteinuria in Liver Transplantation, a Single Egyptian Center Study

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05733754
Collaborator
(none)
70
1
10.1
7

Study Details

Study Description

Brief Summary

Proteinuria has been suggested to be a predictive factor and an important tool for differentiating the etiology of renal dysfunction in various clinical scenarios .The good predictive performance of preoperative proteinuria utilized for the development of renal failure after operation has been reported . In the literature, prognostic significance of several scoring systems for end-stage liver disease has been validated . The Sequential Organ Failure Assessment (SOFA) system was found to be superior to ChildPugh points (CP points) and Model for End-Stage Liver Disease (MELD) score, and postoperative day 7 SOFA had the best discriminative power for predicting 3-month and 1-year mortality after liver transplantation . Renal dysfunction is one of the most significant adverse events in patients awaiting or undergoing a liver transplant, and its occurrence generally indicates a high rate of poor prognosis

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Proteinuria has been suggested to be a predictive factor and an important tool for differentiating the etiology of renal dysfunction in various clinical scenarios .The good predictive performance of preoperative proteinuria utilized for the development of renal failure after operation has been reported . In the literature, prognostic significance of several scoring systems for end-stage liver disease has been validated . The Sequential Organ Failure Assessment (SOFA) system was found to be superior to ChildPugh points (CP points) and Model for End-Stage Liver Disease (MELD) score, and postoperative day 7 SOFA had the best discriminative power for predicting 3-month and 1-year mortality after liver transplantation .Renal dysfunction is one of the most significant adverse events in patients awaiting or undergoing a liver transplant, and its occurrence generally indicates a high rate of poor prognosis .

    In spite of the fact that proteinuria has been increasingly considered as a significant manifestation of acute or chronic renal disease , no study clarify the association between presence of proteinuria and prognosis of patients undergoing liver transplant.

    The aim of the study

    Primary objective:

    Assess proteinuria as an early marker of renal dysfunction for liver transplant.

    Secondary objective:

    Defining different risk factors causing proteinuria.

    Patients and methods

    1. Study design Retrospective study

    2. Inclusion criteria A total of 70 patients with end-stage liver disease received liver transplant will be included.

    3. Exclusion criteria

    • Patients less than 18 years of age.

    • Patients with end-stage renal disease.

    All data of patients will include :
    • Demographic information, etiologies of primary liver disease, clinical parameters, lab investigations including CBC, urea, creatinine, liver enzymes, hepatitis viral markers, CMV infection, lipid profile, fasting and 2hours post prandial glucose level, anesthesia time, operation time, duration of hospitalization and ICU stay, and outcome.

    • Associated medical conditions as diabetes mellitus, hypertension, dyslipidemia .

    • The urinary analysis before transplantation and follow up for 6 months if proteinuria is present .

    • types of immunosuppression taken.

    • Occurrence of dialysis (temporary)

    • Severity of liver disease will be assessed by CP points and MELD score Statistical analysis

    1. An excel sheet well be performed for data collection

    2. Clinical and laboratory data will be statistically analyzed

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    70 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Proteinuria as an Early Prognostic Factor for Detecting Possible Renal Affection After Liver Transplantation, a Single Egyptian Center Study
    Anticipated Study Start Date :
    Mar 1, 2023
    Anticipated Primary Completion Date :
    Oct 1, 2023
    Anticipated Study Completion Date :
    Jan 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Assess incidence of proteinuria as an early marker of renal dysfunction for liver transplant. [Baseline]

      Clarify the association between presence of proteinuria as an early marker of renal dysfunction for liver transplant and prognosis of patients undergoing liver transplant by measurement of serum creatinine clearance and albumin creatinine ratio in urine

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • A total of 70 patients with end-stage liver disease received liver transplant will be included.
    Exclusion Criteria:
    • Patients less than 18 years of age.

    • Patients with end-stage renal disease.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut University Assuit Egypt 71511

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: marwa m abokrsha, MD, Lecturerer of internal medicine Gastroenterology and hepatology
    • Study Chair: Ramy A Hassan, Md, Assistant professor of surgery
    • Study Chair: Ahmed m Taha, MD, Assistant professor of surgery
    • Principal Investigator: Lobna A Ahmed, MD, Professor of internal medicine Gastroenterology and hepatology
    • Principal Investigator: Reem E Mahdy, MD, Consultant of internal medicine and hepatology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Marwa M.Abokresha, principle investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05733754
    Other Study ID Numbers:
    • Proteinuria
    First Posted:
    Feb 17, 2023
    Last Update Posted:
    Feb 17, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 17, 2023