The objectives of our study are (1) to evaluate the correlation between aorto-iliac calcification score and kidney function; (2) to investigate the impact of aorto-iliac calcification on graft survival, patient survival and cardiovascular event-free…
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
- Vascular therapeutic procedures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
The constantly increasing number of aorto-iliac lesions in patients with
end-stage renal disease (ESRD) seems to be the result of three main factors:
increased recipient age, frequent atherosclerosis accompanying with end-stage
renal disease and commonly present metabolic syndrome (diabetes, hypertension
and hypercholesterolemia). These arterial calcifications of the aorta and iliac
vessels are a relative contra-indication for kidney transplantation due to
possible surgical complexity and cardiovascular comorbidity. The impact of
aorto-iliac vascular disease on kidney function, graft survival, surgical
complexity and surgical complications remains poorly explored, as well as the
most suitable diagnostic imaging to classify the severity of aorto-iliac
calcifications.
Frailty is an important topic in kidney transplant recipients who suffer from
aorto-iliac vascular disease due to high prevalence of risk factors associated
with frailty such as increased age and hemodialysis treatment. Frailty can be
measured using Fried frailty index, but it is shown that it can also be
measured by lower extremity function using the validated Short Physical
Performance Battery score (SPPB). Low SPPB has shown to be an independent risk
factor for mortality after kidney transplantation. Prior studies show that
Fried frailty index significantly improves after kidney transplantation. It is
unknown whether low SPPB score pre-transplantation can be restored after kidney
transplantation.
Study objective
The objectives of our study are (1) to evaluate the correlation between
aorto-iliac calcification score and kidney function; (2) to investigate the
impact of aorto-iliac calcification on graft survival, patient survival and
cardiovascular event-free survival; (3) to investigate the impact of
aorto-iliac calcification on surgical complexity and surgical complications;
(4) to determine predictors in patient demographics and physical examination
for significant aorto-iliac vascular disease.
Our sub-study, focusing on frailty in kidney transplant recipients as measured
with Fried frailty index and SPPB score, aims to investigate the influence of
kidney transplantation on Fried frailty index and SPPB score measured 6 months
post-transplantation.
Study design
Prospective, single-center, cohort study
Study burden and risks
The burden for the patient is a pre-transplantation, non-contrast enhanced
abdominal CT-scan which is performed at the day the patient is admitted to the
hospital. This non-contrast enhanced CT-scan is for research only and is
therefore not viewed by the transplant surgeon before surgery. Some patients
already require pre-transplantation imaging because of several comorbidities
associated with a higher risk of aorto-iliac calcification. This decision is
made at the outpatient clinic of transplant surgery and the CT-scan is then
performed after this appointment instead of at the admission day. An abdominal
CT-scan can increase the risk of developing cancer at higher age. However, this
risk is very small when added to the actual life-time risk of developing cancer
(lifetime risk: 1/5, added risk of one abdominal CT-scan: 1/2000).
Fried Frailty score and SPPB score will also be measured at the admission day.
These tests take approximately 30 minutes and consist of questions about
self-experienced health-related problems and an investigation of the gait speed
and balance with five chair-stands test. Post-transplantation Fried frailty
index and SPPB score will be measured 6 months post-transplantation. This
appointment will be planned prior to/after a regular appointment in the
hospital. The measurement of Fried frailty index and SPPB score together takes
approximately 30 minutes to complete. Due to logistic reasons, only patients
with a living kidney donor or a deceased donor who are admitted during working
hours are asked to participate in this sub-study.
Dr Molewaterplein 40
Rotterdam 3015 GD
NL
Dr Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL66269.078.18 |