Kidney Transplant; ComplicationsNCT05797389
Effects of Graft Vascular Dimensions on Surgical and Functional Outcomes of Living Donor Kidney Transplantation
An observational study of Kidney Transplant; Complications, run by Assiut University.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Transplant; Complications
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to Apr 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pediatric and adult patients undergoing living donor kidney transplantation.
Who may be able to join
- Pediatric and adult patients undergoing living donor kidney transplantation.
Who cannot join
- Patients with acute graft rejection occurring within the first week of transplantation.
- Patients refusing participation in the study.
Trial locations and contacts
No sites are listed yet.
About this study
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
- Correlate the radiological and intraoperative measuring of the vascular dimensions,
- Assess the effect of the vascular dimensions on the short-term surgical complications and
- Assess the effect of the vascular dimensions on the primary graft function in pediatric and adults KTs.
Read the detailed 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.
- Conditions
- Kidney Transplant; Complications
- Keywords
- kidney transplantation, renal transplantation, vascular dimensions, vascular parameters
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one month post operative.
2- Rate of decline of the serum creatinine level.
2- Rate of decline of the serum creatinine level.
Measured: one month post operative.
Secondary outcomes (2)
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.
Measured: one month post operative
The rate of other surgical complications.
The rate of other surgical complications.
Measured: one month post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study startApr 2023 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Loay, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797389
- Sponsor's protocol ID
- vascular dimensions and KT
- Status last verified
- Apr 2023
- First submitted
- 21 Mar 2023
- Last updated
- 4 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23671364Fananapazir 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.
PubMed 29500646Dimitroulis 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.
PubMed 19545690Kadakia 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.
PubMed 35131794Meltzer 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.
PubMed 36400588Singh 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.
PubMed 26997403Sevmis 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.
PubMed 32950261Ali-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.
PubMed 12771707Osman 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.
PubMed 12576799Riella 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.
PubMed 36589161
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05797389
- Acronym / sponsor ID
- vascular dimensions and KT
- Conditions
- Kidney Transplant; Complications
- Keywords
- kidney transplantation, renal transplantation, vascular dimensions, vascular parameters
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Correlate the radiological and intraoperative measuring of the vascular dimensions,
- Assess the effect of the vascular dimensions on the short-term surgical complications and
- Assess the effect of the vascular dimensions on the primary graft function in pediatric and adults KTs.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric and adult patients undergoing living donor kidney transplantation.
Key inclusion criteria (1 listed)
- Pediatric and adult patients undergoing living donor kidney transplantation.
Key exclusion criteria (2 listed)
- Patients with acute graft rejection occurring within the first week of transplantation.
- Patients refusing participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mode of graft function defined by: 1- the time of start of diuresis post-transplantation.
Time frame: one month post operative.
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
2- Rate of decline of the serum creatinine level.
Time frame: one month post operative.
2- Rate of decline of the serum creatinine level.
2 secondary outcomes
The rate of vascular complications (intra- or perioperative).
Time frame: one month post operative
The rate of other surgical complications.
Time frame: one month post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Background: PubMed 23671364Srivastava 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.
- Background: PubMed 29500646Fananapazir 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.
- Background: PubMed 19545690Dimitroulis 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.
- Background: PubMed 35131794Kadakia 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.
- Background: PubMed 36400588Meltzer 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.
- Background: PubMed 26997403Singh 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.
- Background: PubMed 32950261Sevmis 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.
- Background: PubMed 12771707Ali-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.
- Background: PubMed 12576799Osman 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.
- Background: PubMed 36589161Riella 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant; Complications, run by Assiut University.
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 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Mohamed L Shehata (00201093590017, mohamed.l.m.sh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mode of graft function defined by: 1- the time of start of diuresis post-transplantation. (time frame: one month post operative.). The study lists 2 primary outcomes in all. 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 NCT05797389, which also lists 10 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 4 Apr 2023.