NCT05797389

Brief Summary

  1. 1.Correlate the radiological and intraoperative measuring of the vascular dimensions,
  2. 2.Assess the effect of the vascular dimensions on the short-term surgical complications and
  3. 3.Assess the effect of the vascular dimensions on the primary graft function in pediatric and adults KTs.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

April 4, 2023

Status Verified

April 1, 2023

Enrollment Period

1.9 years

First QC Date

March 21, 2023

Last Update Submit

April 2, 2023

Conditions

Keywords

kidney transplantationrenal transplantationvascular dimensionsvascular parameters

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 2- Rate of decline of the serum creatinine level.

    2- Rate of decline of the serum creatinine level.

    one month post operative.

Secondary Outcomes (2)

  • The rate of vascular complications (intra- or perioperative).

    one month post operative

  • The rate of other surgical complications.

    one month post operative

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pediatric and adult patients undergoing living donor kidney transplantation.

You may qualify if:

  • Pediatric and adult patients undergoing living donor kidney transplantation.

You may not qualify if:

  • Patients with acute graft rejection occurring within the first week of transplantation.
  • Patients refusing participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • 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.

    PMID: 23671364BACKGROUND
  • 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.

    PMID: 29500646BACKGROUND
  • 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.

    PMID: 19545690BACKGROUND
  • 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.

    PMID: 35131794BACKGROUND
  • 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.

    PMID: 36400588BACKGROUND
  • 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.

    PMID: 26997403BACKGROUND
  • 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.

    PMID: 32950261BACKGROUND
  • 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.

    PMID: 12771707BACKGROUND
  • 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.

    PMID: 12576799BACKGROUND
  • 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.

    PMID: 36589161BACKGROUND

Central Study Contacts

Rabea A Gadelkareem

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

March 21, 2023

First Posted

April 4, 2023

Study Start

April 1, 2023

Primary Completion

March 1, 2025

Study Completion

April 1, 2025

Last Updated

April 4, 2023

Record last verified: 2023-04