The main objective is to study the effect of renal transplantation with a living donor on selected cardiovascular, nutritional and activity parameters in both recipients as well as living donors.
ID
Source
Brief title
Condition
- Nephropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Overhydration; bio-impedance
Pulse wave velocity
Body composition; bio-impedance
Physical activity; sensewear armband
Secondary outcome
capillary microscopy
handgriph strength
laboratory parameters
skin autofluorescense
Background summary
In the life of patients with end-stage renal disease, two major events are the
start of dialysis and, if applicable, renal transplantation, which is seen as
the best possible solution. It is likely that renal transplantation has major
beneficial effects on cardiovascular and nutritional parameters, as well as
volume status and physical activity levels. Whereas many cross-sectional
studies have addressed these parameters in renal transplant patients, few
studies have focused on the longitudinal effects of renal transplantation. This
study may be of relevance in assessing the reversibility of uremic
complications by kidney transplantation.
Also less information is available on the effects of kidney donation from a
living donor. Studies which were conducted on cardiovascular parameters and
body composition parameters are often of retrospective design. For nutritional
parameters and physical activity less is known. This study can provide more
information concerning the recovery of living kidney donors in a longitudinal
setting and show how soon donors are recovered until prédonation levels.
Study objective
The main objective is to study the effect of renal transplantation with a
living donor on selected cardiovascular, nutritional and activity parameters in
both recipients as well as living donors.
Study design
This is a longitudinal observational study, with a follow-up duration of twelve
months.
The study parameters will be assessed before transplantation during a visit at
the pre-transplantation clinic, at the day before renal transplantation, day 1
after renal transplantation, and at 1 week, 1 months, 3 months, 6 months and 12
months after renal transplantation (in total 8 times).
Controls (donors) will be measured three times; before donation, 3 months after
donation and 12 months after donation.
Study burden and risks
In this study, only non-invasive techniques will be performed, which pose a
minimal burden to the patient. Blood sampling will coincide as much as possible
with regular blood takings for clinical purposes. The study will not have
direct benefit for the participants. The study can only be performed within
this specific patient group.
P Debyelaan 25
Maastricht 6229 HX
NL
P Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
Age > or equal to 18 years.
Ability to provide written informed consent.
Patients who will receive a kidney transplant from a living kidney donor.
Exclusion criteria
Patients:
Inability to provide informed consent.
For bioimpedance measurements: presence of ICD or pacemaker. There are no restrictions for other measurements in these patients.;Controls:
Hypertension (blood pressure higher than 170 mm/Hg systolic and higher than 100 mm/Hg diastolic during the screening)
Diabetes mellitus
Active malignancies/infections;Donors are already screened for these exclusion criteria at the pre-transplantation clinic to get approval for kidney donation.
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 | NL43381.068.13 |