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the IMPact of Aorto-iliac Calcifications prior to kidney Transplantation

the IMPact of Aorto-iliac Calcifications prior to kidney Transplantation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON21052
Enrollment
141
Registered
2018-11-28
Start date
2018-12-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Kidney transplant

Interventions

The study design is a prospective, single-center cohort study, carried out in the Erasmus Medical Center, Rotterdam. All patients who meet the eligibility criteria for this study will be asked to part

Sponsors

Erasmus MC, University Medical Center Rotterdam, Dept. of Surgery
Lead Sponsor

Eligibility

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 ¡Ý50 years, or age ¡Ý30 years with at least one of the following risk factors: diabetes mellitus, ¡Ý1 year of hemodialysis, ethnicity from South-Asia, smoking history of at least 10 pack years, history of peripheral arterial disease, ischemic heart disease or a cerebrovascular accident. - The patient has given written informed consent to participate in this study. For the sub-study about frailty, we use the same inclusion and exclusion criteria with the added inclusion criteria that patients receive a living donor kidney transplant or a deceased kidney transplant during working hours due to logistic reasons (Monday-Friday 08:00-18:00).

Exclusion criteria

Exclusion criteria: The following patients are excluded from our study: - Orthotopic kidney transplantation - Autotransplantation - Combined kidney-liver transplantation - Patient has no cardiac clearance to be eligible for kidney transplantation

Design outcomes

Primary

MeasureTime frame
The aim of this study is to evaluate the correlation between aorto-iliac calcification score and transplant function one year after transplantation, as measured with eGFR (using the CKD-EPI formula).

Secondary

MeasureTime frame
Uncensored and death-censored graft survival, patient survival, cardiovascular event-free survival, surgical complications, operation complexity, change in Fried Frailty index and SPPB score

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)