No registrations found.
ID
Source
Brief title
Health condition
Not applicable
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome: Mean perfused vessel density difference between different time points will analysed by using paired T-tests.
Secondary outcome
Secondary outcome: Mean total vessel density difference between different time points will analysed by using paired T-tests.
Background summary
Rationale:
Recent studies comparing equally healthy controls with donors suggest that living kidney donation is associated with increased risk of developing cardiovascular disease. However, mechanisms underlying this possible association remain unknown. In this study, we aim to investigate whether microcirculatory perfusion becomes compromised after unilateral nephrectomy in living donors in order to get more insight in the possible mechanism behind the development of CVD after kidney donation.
Objective:
To study microcirculatory perfusion in living kidney donors before and after donation.
Study design:
Single center, prospective observational study
Study population:
Living kidney donors > 18 years of age.
Intervention (if applicable):
Not applicable
Main study parameters/endpoints:
The primary outcome is to study the difference in perfused and total vessel density before and after unilateral nephrectomy in living kidney donors.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
There will be no benefit for patients participating in this study. The use of the USB3 MicroScan imaging camera is a non-invasive sublingually measurement technique which exposes patients to minimal risk and burden.
Study objective
Hypothesis: We hypothesize that perfused and total micro vessel density in living kidney donors will be decreased after kidney donation.
Study design
Time points: 1 day before donation and 3 weeks after donation.
Intervention
Not applicable
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Age > 18
- Living kidney donors
- Provision of written informed consent
Exclusion criteria
Exclusion criteria:
- If candidate cannot understand Dutch or English.
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7566 |
| CCMO | NL65200.029.18 |
| OMON | NL-OMON46695 |