AzTrials
AzTrials

Liver Transplant; ComplicationsNCT05733754

Proteinuria in Liver Transplantation, a Single Egyptian Center Study

An observational study of Liver Transplant; Complications, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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 . Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Liver Transplant; Complications
How many people
70 participants
Where
1 siteEgypt
Study dates
Mar 2023to Jan 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

marwa m abokrsha, MD contact

01000580208 ext. +2

marwainternalmedicine@gmail.com

Reem e Mahdy, MD contact

01096608866 ext. +2

reemezzat1@gmail.com

Egypt1 site

  • Assiut University

    Asyut, 71511

    Marwa M Abokresha, Master, 01000580208 ext. +2, marwainternalmedicine@gmail.com

Other trials in Egypt

About this study

Official title: 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

Read the 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2023
  2. Study startMar 2023 (estimated)
  3. Primary completionOct 2023 (estimated)
  4. Study completionJan 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05733754
Sponsor's protocol ID
Proteinuria
Status last verified
Feb 2023
First submitted
26 Feb 2022
Last updated
17 Feb 2023
Results posted
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 20686930

  • 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.

    PubMed 21885792

  • 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.

    PubMed 21115618

  • 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.

    PubMed 11481609

  • 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.

    PubMed 16886911

  • 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.

    PubMed 25208465

  • 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.

    PubMed 20104481

Questions about this trial

What is this clinical trial studying?

An observational study of Liver Transplant; Complications, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact marwa m abokrsha, MD (01000580208 ext. +2, marwainternalmedicine@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess incidence of proteinuria as an early marker of renal dysfunction for liver transplant. (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05733754, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in