the IMPact of Aorto-iliac Calcifications prior to kidney Transplantation

the IMPact of Aorto-iliac Calcifications prior to kidney Transplantation - IMPACT study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45996

Enrollment

141

Registered

2018-11-08

Start date

2018-12-07

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aorto-iliac calcifications aorto-iliac vascular disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Our primary outcome is the correlation between calcification score and kidney function 1-year post-transplantation as measured with the estimated Glomerular Filtration Rate (eGFR) using the Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI). Our secondary outcomes are (death-censored) graft survival, patient survival, cardiovascular event-free survival, surgical complications and operation complexity (scored by the transplant surgeon and as measured with operation duration). The primary outcome of the sub-study is change in Fried frailty index and SPPB score 6 months post-transplantation.	—

Measure

Time frame

Our primary outcome is the correlation between calcification score and kidney function 1-year post-transplantation as measured with the estimated Glomerular Filtration Rate (eGFR) using the Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI). Our secondary outcomes are (death-censored) graft survival, patient survival, cardiovascular event-free survival, surgical complications and operation complexity (scored by the transplant surgeon and as measured with operation duration). The primary outcome of the sub-study is change in Fried frailty index and SPPB score 6 months post-transplantation.

—

Secondary

Measure	Time frame
1. (death-censored) Graft survival at 1 year and 3 years 2. Cardiovascular event-free survival at 1 year and 3 years 3. Patient survival at 1 year and 3 years 4. Incidence of complications after surgery 5. Operation complexity 6. Change in Fried frailty index and SPPB score post-transplantation	—

Countries

Netherlands

Outcome results