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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06123260
Other study ID # renal outcomes post OLT
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 1, 2023
Est. completion date January 1, 2025

Study information

Verified date November 2023
Source Assiut University
Contact Ebram Magdy Eskander, M.B.B.Ch
Phone 01116094001
Email ebrammagdy93@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

To evaluate Renal outcomes among patients, post liver transplantation at Assiut university.


Description:

It is estimated that 1 in 4 liver transplantation (LT) recipients has an estimated glomerular filtration rate (eGFR) of <60mL/minute/1.73 m2 at the time of LT Renal dysfunction, both before or after LT, is an important comorbidity associated with an increased risk of death, morbidity, and cost. Serum creatinine, a major component of the Model for End-Stage Liver Disease (MELD) score, has driven the increased incidence of renal dysfunction among patients undergoing LT End-stage liver disease (ESLD) is commonly complicated by kidney dysfunction, which in turn leads to a worse prognosis. The kidney dysfunction can be functional or structural, ranging from prerenal azotemia and hepatorenal syndrome causing acute kidney injury to immunoglobulin A (IgA) nephropathy (IgAN) and membranoproliferative glomerulonephritis causing chronic kidney disease Each condition carries a different presentation, treatment, prognosis, and risk of recurrence. Therefore, when ESLD patients undergo evaluation for liver transplant, it is critical to assess their kidney function and understand the cause of any underlying kidney dysfunction LT recipients will continue to worsen due to calcineurin inhibitor toxicity and lack of recovery from hepatorenal syndrome (HRS), necessitating renal replacement therapy Patients who are not expected to recover their kidney function after liver transplant usually benefit from combined liver and kidney transplant (CLKT). Others may need modified immunosuppressive regimens that minimize or avoid use of calcineurin inhibitors to preserve the remaining kidney function. For assessment of kidney function, Equations that estimate GFR are most commonly used in daily practice. They have the advantage of being inexpensive and results are immediately available. Their disadvantage is that they rely on endogenous biomarkers, which are confounded by non-GFR determinants such as age, sex, muscle mass, drugs, certain chronic conditions, diet and presumably many more Creatinine, the most commonly used biomarker, depends heavily on muscle mass. Pre and intraoperative factors and postoperative complications were evaluated for their impact on development of AKI The preoperative factors MELD, SCr, Bilirubin and INR were highly associated with an increased risk for developing AKI requiring RRT for the post OLT complications, length of ICU stay was associated with the development of AKI Patients with a longer ventilation time and a higher amount of RPC transfusion were more likely to have AKI requiring RRT, whereas these parameters were not associated with milder forms of AKI.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date January 1, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Data of all Patients underwent liver transplants with their reports available at El Raghy university hospital Exclusion Criteria: - Inadequate data - Patients on dialysis more than 8 weeks pre liver transplant.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
renal function tests
BUN, eGFR , CBC , Electrolytes , Liver function tests

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (7)

Blom E. A decapitated sperm defect in two sterile Hereford bulls. Nord Vet Med. 1977 Mar;29(3):119-23. — View Citation

Braun OH, Kreipe U. [Rare forms of chronic osteomyelitis in children (author's transl)]. Klin Padiatr. 1979 Sep;191(5):511-21. German. — View Citation

Feffer SE, Parray HR, Westring DW. Seizure after infusion of aminocaproic acid. JAMA. 1978 Nov 24;240(22):2468. No abstract available. — View Citation

Pannuti F. Surgical adjuvant hormone therapy in breast cancer. Arch Geschwulstforsch. 1978;48(7):680-2. No abstract available. — View Citation

Pozenel H. [The influence of mexiletin on ventricular arrhythmias during ergometric exercise (author's transl)]. Wien Klin Wochenschr. 1977 Dec 9;89(23):783-8. German. — View Citation

Ramakrishnan R, Mittal S, Ambatkar S, Kader MA. Retinal nerve fibre layer thickness measurements in normal Indian population by optical coherence tomography. Indian J Ophthalmol. 2006 Mar;54(1):11-5. doi: 10.4103/0301-4738.21608. — View Citation

Rautela GS, Snee RD, Miller WK. Response-surface co-optimization of reaction conditions in clinical chemical methods. Clin Chem. 1979 Nov;25(11):1954-64. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary calculation the incidence of AKI in Liver transplantation patients Determination of the most common risk factor for AKI in liver transplantation patients. Baseline
Secondary mortality rate patient survival in post LT AKI group. Baseline
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