Predictors of Outcome of Pediatric Renal Transplantation

NCT ID: NCT06708988

Last Updated: 2024-11-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-12-30

Brief Summary

Renal transplantation is a unique chance to a normal life for end-stage renal disease patients, because of the perfect morphological and functional replacement of the lost kidneys. Serum creatinine and proteinuria reflect kidney allograft function, but they are nonspecific tools.Imaging techniques plays an important role in the detection of anatomical as well as functional abnormalities in the early stages.

Detailed Description

Renal transplantation is a unique chance to a normal life for end-stage renal disease patients, because of the perfect morphological and functional replacement of the lost kidneys. It is also the only effective way of replacement of the endocrine function of the kidneys. The survival of kidney grafts has improved considerably in recent years, due to advances in surgical techniques and in immunosupression protocols . Although improvements in surgical techniques and immunosuppression have led to longer survival, complications remain common, occurring in approximately 12%-20% of patients. Post transplantation complications can also be divided following the renal transplant's time of evolution into early complications (acute tubular necrosis, acute rejection, arterial or venous thrombosis, obstruction, urinary leak, post transplantation collections and infection) and late complications (transplant artery stenosis, arteriovenous fistulas, drugs toxicity, chronic rejection and urinary tract infection). Acute rejection (AR) is a major risk factor for chronic nephropathy and graft loss after renal transplantation (RT) . Antibody-mediated rejection (AMR) is the most common cause of allograft failure in kidney transplant recipients (KTRs) . Serum creatinine and proteinuria reflect kidney allograft function, but they are nonspecific tools. Despite its limitations (being invasive procedure with increased risk of bleeding and infection), kidney graft biopsy remains the gold standard method for confirming antibody-mediated rejection . Whilst kidney graft dysfunction could present with an elevated serum creatinine level, oliguria or pain over the graft site, it could also be asymptomatic. Imaging techniques plays an important role in the detection of anatomical as well as functional abnormalities in the early stages, thus allowing the chance for early treatment, as well as in the late post transplant period . Post-transplant complications can be divided into categories following the imaging-based classification of renal transplant complications: Perinephric collections, parenchymal abnormalities, abnormalities of the collecting system and vascular complications . The use of ultrasound to assess morphologic changes allows for the accurate and early detection of early pathologic alterations that may lead to rejection . Correlation of the ultrasound pattern with patient's history and clinical background is essential for a correct characterization. However, there are several limitations to ultrasound including its inability to assess renal function or differentiate between the different causes of renal dysfunction . Color Doppler ultrasonography, on the other hand, gives valuable information on the hemodynamics of the grafts' renal arteries. In the early post-transplant period, the resistive index(RI) measured in intrarenal arteries is thought to predict poor kidney graft performance . Doppler indices in different arteries differ in the detection of early parenchymal renal transplant complications. Resistive index of the interlobar artery proved to be more specific in the detection of early cases of parenchymal complications in a renal transplant patient . Color Doppler sonography had a limited value in the differentiation among the various etiologies of renal transplant dysfunction however the mean RI values were above normal in acute rejection and ATN . Vitamin D deficiency or vitamin D insufficiency is common and conflicting results concerning vitamin D deficiency -associated graft failure and mortality were described in kidney transplant recipients (KTRs). Many studies showed that Vitamin D deficiency , measured as 25-hydroxyvitamin D [25(OH)D] or 1,25-dihydroxyvitamin D [1,25(OH)2D], relates to kidney dysfunction in renal disease and graft loss in kidney transplant recipients . The association between low 1,25(OH)2D and graft failure was seen and was dependent on renal function. This association is not unexpected since the 1a-hydroxylase of the kidney, i.e., the enzyme that converts 25(OH)D into 1,25(OH)2D, is damaged simultaneously with the deterioration of renal function.

Conditions

Pediatric Renal Transplantation Complication

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• All pediatric patients aged 1 to 18 years old
• first renal transplant during the first year, pre and post complications.

Exclusion Criteria

• patients with recurrent renal transplantation.
• Parental refusal to participate.
• Patients with chronic rejection

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Merna Nazeer,MD

Assisstant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maher Mokhtar, Professor

Role: STUDY_DIRECTOR

Assiut University

Ahlam badwy, A.Professor

Role: STUDY_DIRECTOR

Assiut University

Asmaa Ahmed, Lecturer

Role: STUDY_DIRECTOR

Assiut University

Merna Ezzat, A. lecturer

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

Merna Ezzat, A.lecturer

Role: CONTACT

mernaezzat852456@gmail.com

01223554098

References

Lim WH, Johnson DW, Teixeira-Pinto A, Wong G. Association Between Duration of Delayed Graft Function, Acute Rejection, and Allograft Outcome After Deceased Donor Kidney Transplantation. Transplantation. 2019 Feb;103(2):412-419. doi: 10.1097/TP.0000000000002275.

Reference Type: BACKGROUND

PMID: 29762458 (View on PubMed)

Takimoto Y, Imanaka F. [Chronic myelomonocytic leukemia with repeated respiratory failure associated with leukocytosis following splenic arterial embolization and splenectomy]. Rinsho Ketsueki. 1996 Nov;37(11):1253-8. Japanese.

Reference Type: BACKGROUND

PMID: 8960657 (View on PubMed)

Kim N, Juarez R, Levy AD. Imaging non-vascular complications of renal transplantation. Abdom Radiol (NY). 2018 Oct;43(10):2555-2563. doi: 10.1007/s00261-018-1566-4.

Reference Type: BACKGROUND

PMID: 29550956 (View on PubMed)

Bouatou Y, Viglietti D, Pievani D, Louis K, Duong Van Huyen JP, Rabant M, Aubert O, Taupin JL, Glotz D, Legendre C, Loupy A, Lefaucheur C. Response to treatment and long-term outcomes in kidney transplant recipients with acute T cell-mediated rejection. Am J Transplant. 2019 Jul;19(7):1972-1988. doi: 10.1111/ajt.15299. Epub 2019 Mar 15.

Reference Type: BACKGROUND

PMID: 30748089 (View on PubMed)

Schinstock CA, Mannon RB, Budde K, Chong AS, Haas M, Knechtle S, Lefaucheur C, Montgomery RA, Nickerson P, Tullius SG, Ahn C, Askar M, Crespo M, Chadban SJ, Feng S, Jordan SC, Man K, Mengel M, Morris RE, O'Doherty I, Ozdemir BH, Seron D, Tambur AR, Tanabe K, Taupin JL, O'Connell PJ. Recommended Treatment for Antibody-mediated Rejection After Kidney Transplantation: The 2019 Expert Consensus From the Transplantion Society Working Group. Transplantation. 2020 May;104(5):911-922. doi: 10.1097/TP.0000000000003095.

Reference Type: BACKGROUND

PMID: 31895348 (View on PubMed)

Mirzakhani M, Shahbazi M, Akbari R, Dedinska I, Nemati E, Mohammadnia-Afrouzi M. Soluble CD30, the Immune Response, and Acute Rejection in Human Kidney Transplantation: A Systematic Review and Meta-Analysis. Front Immunol. 2020 Feb 28;11:295. doi: 10.3389/fimmu.2020.00295. eCollection 2020.

Reference Type: BACKGROUND

PMID: 32256486 (View on PubMed)

Madubueze AG. Early Sonographic Evaluation of Intrarenal Arterial Resistive Index and Long-term Renal Function in Renal Transplant Recipients in South Western Nigeria. J Med Ultrasound. 2020 Mar 5;28(3):156-161. doi: 10.4103/JMU.JMU_82_19. eCollection 2020 Jul-Sep.

Reference Type: BACKGROUND

PMID: 33282659 (View on PubMed)

Galgano SJ, Lockhart ME, Fananapazir G, Sanyal R. Optimizing renal transplant Doppler ultrasound. Abdom Radiol (NY). 2018 Oct;43(10):2564-2573. doi: 10.1007/s00261-018-1731-9.

Reference Type: BACKGROUND

PMID: 30121777 (View on PubMed)

Meier M, Fricke L, Eikenbusch K, Smith E, Kramer J, Lehnert H, Nitschke M. The Serial Duplex Index Improves Differential Diagnosis of Acute Renal Transplant Dysfunction. J Ultrasound Med. 2017 Aug;36(8):1607-1615. doi: 10.7863/ultra.16.07032. Epub 2017 Apr 3.

Reference Type: BACKGROUND

PMID: 28370148 (View on PubMed)

de Braganca AC, Canale D, Goncalves JG, Shimizu MHM, Seguro AC, Volpini RA. Vitamin D Deficiency Aggravates the Renal Features of Moderate Chronic Kidney Disease in 5/6 Nephrectomized Rats. Front Med (Lausanne). 2018 Oct 10;5:282. doi: 10.3389/fmed.2018.00282. eCollection 2018.

Reference Type: BACKGROUND

PMID: 30370270 (View on PubMed)

Russell SE. Passing the hot potato--voluntary disclosure and Operation Restore Trust. Caring. 1996 Feb;15(2):36-9. No abstract available.

Reference Type: BACKGROUND

PMID: 10156982 (View on PubMed)

Related Links

https://dx.doi.org/10.1594/ecr2017/C-1274

Complications of renal transplantation: Diagnosis and treatment

https://dx.doi.org/10.21608/amj.2023.326112

ROLE OF RENAL ULTRASONOGRAPHY AND DOPPLER IN DETECTION OF COMPLICATIONS OF POST-TRANSPLANTED KIDNEY

Other Identifiers

Kidney transplantation

Identifier Type: -

Identifier Source: org_study_id