the IMPact of Aorto-iliac Calcifications prior to kidney Transplantatio
- Conditions
- Aorto-iliac calcificationsaorto-iliac vascular disease100384301000318410003216
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 141
In order to be eligible to participate in this study, a patient must meet all of the following criteria:
- The patient is mentally competent
- The patient is suffering from end-stage renal disease stage IV/V.
- The patient is eligible for kidney transplantation as decided at the outpatient clinic of transplant surgery.
- The age of the patient is >=50 years, or age >=30 years with at least one of the following risk factors: diabetes mellitus, >=1 year of hemodialysis, ethnicity from South-Asia, smoking history of at least 10 packyears, history of peripheral arterial disease, ischemic heart disease or a cerebrovascular accident.
- The patient has given written informed consent to participate in this study.
The following patients are excluded from our study:
- Patients receiving an orthotopic kidney transplantation
- Patients receiving a combined kidney-liver transplantation
- Patients without cardiac clearance to be eligible for kidney transplantation
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Our primary outcome is the correlation between calcification score and kidney<br /><br>function 1-year post-transplantation as measured with the estimated Glomerular<br /><br>Filtration Rate (eGFR) using the Chronic Kidney Disease Epidemiology<br /><br>Collaboration formula (CKD-EPI). Our secondary outcomes are (death-censored)<br /><br>graft survival, patient survival, cardiovascular event-free survival, surgical<br /><br>complications and operation complexity (scored by the transplant surgeon and as<br /><br>measured with operation duration). The primary outcome of the sub-study is<br /><br>change in Fried frailty index and SPPB score 6 months post-transplantation.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. (death-censored) Graft survival at 1 year and 3 years<br /><br>2. Cardiovascular event-free survival at 1 year and 3 years<br /><br>3. Patient survival at 1 year and 3 years<br /><br>4. Incidence of complications after surgery<br /><br>5. Operation complexity<br /><br>6. Change in Fried frailty index and SPPB score post-transplantation</p><br>
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