The main of objectives are to study the effect of the start of dialysis treatment (hemodialysis and peritoneal transplantation), on selected cardiovascular, nutritional parameters as well as physical activity. Secondly, a differentiation will be…
ID
Source
Brief title
Condition
- Nephropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
overhydration (bioimpedance)
pulse wave analysis
body composition (bioimpedance)
physical activity (Sensewear armband)
Secondary outcome
capillary microscopy
handgrip strength
laboratory parameters
skin autofluorescence
Background summary
In the life of patients with end-stage renal disease, the start of dialysis is
a major life event. Many dialysis patients suffer from cardiovascular disease
and malnutrition, and their physical activity levels are low. It is difficult
to unravel the effects of uremia on these parameters of those from dialysis
treatment. The aim of this study is to assess the effects of dialysis on
cardiovascular and nutritional parameters, as well as physical activity levels.
This study may be of relevance given the uncertainties of the optimal time
point to start dialysis.
Study objective
The main of objectives are to study the effect of the start of dialysis
treatment (hemodialysis and peritoneal transplantation), on selected
cardiovascular, nutritional parameters as well as physical activity. Secondly,
a differentiation will be made between patients who start treatment with
peritoneal dialysis or hemodialysis.
Study design
This is a longitudinal observational study, with a follow-up duration of 12-15
months. Measurements will be performed at 6 different point in time. Except for
blood sampling, this is a non-interventional study with non-invasive
measurements. Blood sampling will as much as possible co-incide with regular
sampling moments. The interventions which are studied (dialysis,
transplantation) are part of usual patient care.
Study burden and risks
in this study, only non-invasive techniques 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 with 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
Voorgenomen start van dialysebehandeling (patienten)
Exclusion criteria
An acute start of dialysis treatment, i.e. patients who did not visit the pre-dialysis out-patient clinic on forehand. Reason for exclusion is the fact that in these patients often acute and intercurrent diseases are present, which may significantly interfere with the measurements.
Inability to provide informed consent
Active symptomatic coronary artery disease NYHA III or higher, or cardiac failure NYHA III or higher
Active malignancies
Active infections;Hypertension (blood pressure higher than 170 mmHg systolic or 100 mmHg diastolic at the time of screening) [controls]
Diabetes mellitus [controls]
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 | NL33129.068.10 |