Proteinuria in Liver Transplantation, a Single Egyptian Center Study

NCT05733754 | Unknown

• 1 other identifier: Proteinuria
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Liver Transplant; Complications

Outcome Measures

Primary Outcomes (1)

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

  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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• Patients less than 18 years of age.
• Patients with end-stage renal disease.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 71511, Egypt

Location

Related Publications (7)

• Glassock RJ. Is the presence of microalbuminuria a relevant marker of kidney disease? Curr Hypertens Rep. 2010 Oct;12(5):364-8. doi: 10.1007/s11906-010-0133-3.

  PMID: 20686930 BACKGROUND

• Heller F, Frischmann S, Grunbaum M, Zidek W, Westhoff TH. Urinary calprotectin and the distinction between prerenal and intrinsic acute kidney injury. Clin J Am Soc Nephrol. 2011 Oct;6(10):2347-55. doi: 10.2215/CJN.02490311. Epub 2011 Sep 1.

  PMID: 21885792 BACKGROUND

• Huang TM, Wu VC, Young GH, Lin YF, Shiao CC, Wu PC, Li WY, Yu HY, Hu FC, Lin JW, Chen YS, Lin YH, Wang SS, Hsu RB, Chang FC, Chou NK, Chu TS, Yeh YC, Tsai PR, Huang JW, Lin SL, Chen YM, Ko WJ, Wu KD; National Taiwan University Hospital Study Group of Acute Renal Failure. Preoperative proteinuria predicts adverse renal outcomes after coronary artery bypass grafting. J Am Soc Nephrol. 2011 Jan;22(1):156-63. doi: 10.1681/ASN.2010050553. Epub 2010 Nov 29.

  PMID: 21115618 BACKGROUND

• Wehler M, Kokoska J, Reulbach U, Hahn EG, Strauss R. Short-term prognosis in critically ill patients with cirrhosis assessed by prognostic scoring systems. Hepatology. 2001 Aug;34(2):255-61. doi: 10.1053/jhep.2001.26522.

  PMID: 11481609 BACKGROUND

• Cholongitas E, Senzolo M, Patch D, Shaw S, Hui C, Burroughs AK. Review article: scoring systems for assessing prognosis in critically ill adult cirrhotics. Aliment Pharmacol Ther. 2006 Aug 1;24(3):453-64. doi: 10.1111/j.1365-2036.2006.02998.x.

  PMID: 16886911 BACKGROUND

• Pan HC, Jenq CC, Tsai MH, Fan PC, Chang CH, Chang MY, Tian YC, Hung CC, Fang JT, Yang CW, Chen YC. Scoring systems for 6-month mortality in critically ill cirrhotic patients: a prospective analysis of chronic liver failure - sequential organ failure assessment score (CLIF-SOFA). Aliment Pharmacol Ther. 2014 Nov;40(9):1056-65. doi: 10.1111/apt.12953. Epub 2014 Sep 11.

  PMID: 25208465 BACKGROUND

• Wong CS, Lee WC, Jenq CC, Tian YC, Chang MY, Lin CY, Fang JT, Yang CW, Tsai MH, Shih HC, Chen YC. Scoring short-term mortality after liver transplantation. Liver Transpl. 2010 Feb;16(2):138-46. doi: 10.1002/lt.21969.

  PMID: 20104481 BACKGROUND

Study Officials

• marwa m abokrsha, MD

  Lecturerer of internal medicine Gastroenterology and hepatology

  PRINCIPAL INVESTIGATOR

• Ramy A Hassan, Md

  Assistant professor of surgery

  STUDY CHAIR

• Ahmed m Taha, MD

  Assistant professor of surgery

  STUDY CHAIR

• Lobna A Ahmed, MD

  Professor of internal medicine Gastroenterology and hepatology

  PRINCIPAL INVESTIGATOR

• Reem E Mahdy, MD

  Consultant of internal medicine and hepatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

marwa m abokrsha, MD

CONTACT

01000580208; marwainternalmedicine@gmail.com

Reem e Mahdy, MD

CONTACT

01096608866; reemezzat1@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: February 26, 2022
• First Posted: February 17, 2023
• Study Start: March 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: January 1, 2024
• Last Updated: February 17, 2023

Record last verified: 2023-02

Locations

EG (1)