Aim of the present study is to test the hypothesis tha during inflammatory episodes there is a decline in lean body and fat mass and that this results in an increase in extracellular volume in dialysis patients because dry weight is not or…
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The parameters of the study are a bioimpedance measurement, a handgrip test, a
questionnaire, an inspection of the fat and muscle mass and blood samples for
CRP and Troponin T levels.
Secondary outcome
0
Background summary
Overhydration ( an excess of body water) is commonly present in dialysis
patients.
Overhydration may lead to silent myocardial ischemia, although this has not
been formally studied. Recent studies found a relation between extracellular
volume and C-reactive protein levels, a marker of inflammation. The first
explanation is that overhydration itself may induce inflammation. An
alternative explanation is loss of lean body mass in the inflammatory state
which leads to progressive overhydration if not appropriately detected and
treated.
Study objective
Aim of the present study is to test the hypothesis tha during inflammatory
episodes there is a decline in lean body and fat mass and that this results in
an increase in extracellular volume in dialysis patients because dry weight is
not or insufficiently adjusted.
The second hypothesis that is to be tested is that overhydration is related to
subclinical changes in Troponin T as a marker of silent coronary ischemia.
Study design
This is a longitudinal cohort study with a follow-up period of 6 months.
Measurements will be performed every 2 months and also when a patient is
admitted to the hospital for a clinical event or for surgery. Three days after
admission of the patient measurements will be performed and this will be
repeated every three days with a maximum of two. In case of recurrent
hospitalization, patients will not more than two hospitalization episodes be
assessed.
Study burden and risks
This is a non-invasive study with no risks for patinets. The extra amount of
blood taken from the patient will be no more than 60 milliltres the entire
study.
Postbus 5800
6202 AZ
Nederland
Postbus 5800
6202 AZ
Nederland
Listed location countries
Age
Inclusion criteria
Treatment with hemodialysis or peritoneal dialysis
Exclusion criteria
pacemaker
onmogelijkheid om informed consent te geven
Design
Recruitment
Medical products/devices used
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 | NL12014.068.06 |