Proteinuria in Liver Transplantation, a Single Egyptian Center Study

February 8, 2023 updated by: Marwa M.Abokresha, Assiut University

Proteinuria as an Early Prognostic Factor for Detecting Possible Renal Affection After Liver Transplantation, a Single Egyptian Center Study

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

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess incidence of proteinuria as an early marker of renal dysfunction for liver transplant.
Time Frame: 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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

February 26, 2022

First Submitted That Met QC Criteria

February 8, 2023

First Posted (Actual)

February 17, 2023

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

February 8, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Proteinuria

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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