Trials / Unknown
UnknownNCT05733754
Proteinuria in Liver Transplantation, a Single Egyptian Center Study
Proteinuria as an Early Prognostic Factor for Detecting Possible Renal Affection After Liver Transplantation, a Single Egyptian Center Study
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 70 (estimated)
- Sponsor
- Assiut University · Academic / Other
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- —
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
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
Conditions
Timeline
- Start date
- 2023-03-01
- Primary completion
- 2023-10-01
- Completion
- 2024-01-01
- First posted
- 2023-02-17
- Last updated
- 2023-02-17
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT05733754. Inclusion in this directory is not an endorsement.