Effects of Graft Vascular Dimensions on Surgical and Functional Outcomes of Living Donor Kidney Transplantation

Kidney Transplant; Complications Clinical Trial

Official title:

Effects of Graft Vascular Dimensions on Perioperative Surgical and Functional Outcomes of Living Donor Kidney Transplantation in Pediatrics and Adults: A Prospective Case Series

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05797389
• Other study ID #: vascular dimensions and KT
• Status: Not yet recruiting
• Start date: April 2023
• Est. completion date: April 2025

Study information

• Verified date: April 2023
• Source: Assiut University
• Contact: Mohamed L Shehata
• Phone: 00201093590017
• Email: mohamed.l.m.sh[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

1. Correlate the radiological and intraoperative measuring of the vascular dimensions,

2. Assess the effect of the vascular dimensions on the short-term surgical complications and

3. Assess the effect of the vascular dimensions on the primary graft function in pediatric and adults KTs.

Description:

Vascular complications after kidney transplantation (KT) are variably rare with an incidence of 3-15%. They are a significant and most serious part of surgical complications of KT. They may acutely result in graft loss during surgery or early in the perioperative period and may threaten patient's life. The most common forms of early vascular complications are haemorrhage, hematomas, arterial or venous thrombosis, arterial vasospasm, and arterial intimal dissection. In pediatric and adult KT, most studies addressing the vascular complications followed a common attitude of estimating the prevalence and management of these complications rather than studying the predisposing factors. Specifically, studying the normal and abnormal anatomy of the grafts has mainly been directed towards the number of graft vessels. However, there are many other vascular parameters that may potentially influence the outcome of vascular anastomosis and therefore the graft and patient outcomes. To the best of the investigators knowledge, the vascular dimensions of the renal and iliac vessels, such as the length, diameter and site of anastomosis to the iliac vessels have not been studied before so the investigators hypothesis that these dimensions can unequally affect the outcomes of surgery and early graft function in KTs. Hence, this study will be conducted to assess the effects of the vascular dimensions on the outcomes of surgery and primary graft function in pediatric versus adult living donor KT.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pediatric and adult patients undergoing living donor kidney transplantation.

Exclusion Criteria:

• Patients with acute graft rejection occurring within the first week of transplantation.

• Patients refusing participation in the study.

Related Conditions & MeSH terms

• Kidney Transplant; Complications

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (10)

Ali-El-Dein B, Osman Y, Shokeir AA, Shehab El-Dein AB, Sheashaa H, Ghoneim MA. Multiple arteries in live donor renal transplantation: surgical aspects and outcomes. J Urol. 2003 Jun;169(6):2013-7. doi: 10.1097/01.ju.0000067637.83503.3e. — View Citation

Dimitroulis D, Bokos J, Zavos G, Nikiteas N, Karidis NP, Katsaronis P, Kostakis A. Vascular complications in renal transplantation: a single-center experience in 1367 renal transplantations and review of the literature. Transplant Proc. 2009 Jun;41(5):1609-14. doi: 10.1016/j.transproceed.2009.02.077. — View Citation

Fananapazir G, Troppmann C. Vascular complications in kidney transplant recipients. Abdom Radiol (NY). 2018 Oct;43(10):2546-2554. doi: 10.1007/s00261-018-1529-9. — View Citation

Kadakia Y, Hwang C, MacConmara M. Rescue of an asymptomatic arterial occlusion after kidney transplant. BMJ Case Rep. 2022 Feb 7;15(2):e247347. doi: 10.1136/bcr-2021-247347. — View Citation

Meltzer AZ, Fintha A, Cseprekal O, Somogyi D, Szabo J, Kobori L, Rozsa B, Piros L, Huszty G. Graft Arterial Dissection and Thrombosis After Kidney Transplantation With Undiagnosed Fibromuscular Dysplasia From a Deceased Donor: Case Report and Review. Transplant Proc. 2022 Nov;54(9):2603-2607. doi: 10.1016/j.transproceed.2022.10.049. Epub 2022 Nov 16. — View Citation

Osman Y, Shokeir A, Ali-el-Dein B, Tantawy M, Wafa EW, el-Dein AB, Ghoneim MA. Vascular complications after live donor renal transplantation: study of risk factors and effects on graft and patient survival. J Urol. 2003 Mar;169(3):859-62. doi: 10.1097/01.ju.0000050225.74647.5a. — View Citation

Riella J, Tabbara MM, Alvarez A, DeFreitas MJ, Chandar J, Gaynor JJ, Gonzalez J, Ciancio G. Pediatric kidney transplants with multiple renal arteries show no increased risk of complications compared to single renal artery grafts. Front Pediatr. 2022 Dec 16;10:1058823. doi: 10.3389/fped.2022.1058823. eCollection 2022. — View Citation

Sevmis M, Demir ME, Merhametsiz O, Aktas S, Sevmis S, Uyar M. Grafts With Multiple Renal Arteries in Kidney Transplantation. Transplant Proc. 2021 Apr;53(3):933-940. doi: 10.1016/j.transproceed.2020.07.019. Epub 2020 Sep 17. — View Citation

Singh D, Butala BP, Parikh GP. Acute renal artery spasm during live kidney transplant surgery due to iatrogenic cause. Saudi J Kidney Dis Transpl. 2016 Mar;27(2):415-6. doi: 10.4103/1319-2442.178588. No abstract available. — View Citation

Srivastava A, Kumar J, Sharma S, Abhishek, Ansari MS, Kapoor R. Vascular complication in live related renal transplant: An experience of 1945 cases. Indian J Urol. 2013 Jan;29(1):42-7. doi: 10.4103/0970-1591.109983. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mode of graft function defined by: 1- the time of start of diuresis post-transplantation.	Mode of graft function defined by: 1- the start of diuresis (sufficient amount of urine production) within one hour of declamping through the first week post-transplantation	one month post operative.
Primary	2- Rate of decline of the serum creatinine level.	2- Rate of decline of the serum creatinine level.	one month post operative.
Secondary	The rate of vascular complications (intra- or perioperative).	The rate of vascular complications (intra- or perioperative): In the form of spasm, hemorrhage, dissection, or thrombosis.	one month post operative
Secondary	The rate of other surgical complications.	The rate of other surgical complications.	one month post operative