The primary objective of this study is to explore characteristics (nutritional status, body composition, and presence of comorbidities) of HD patients related to successful individual application of bio-electrical impedance to determine the endpoint…
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint constitutes whether BIA can be successfully used to
determine the endpoint of HD treatment. *Success* is hereby defined as post-HD
normovolemia as assessed by BIA.
Secondary outcome
Secondary parameters include nutritional status, body composition, and the
presence of comorbidities.
Background summary
Determining the optimal endpoint for haemodialysis treatment is essential to
prevent symptoms related to over- or underhydration. Currently, objective
measures are lacking. Bioimpedance analysis is deemed a promising tool to aid
in the clinical decision-making process, but large interpersonal differences
are observed regarding the interpretability of results. Since potential
bioimpedance-guided fluid management will be performed on an individual level,
it is imperative that results can be interpreted reliably among different
patients. The inconsistencies suggest that patient characteristics, which have
not yet been identified, may contribute to its successful individual
application in clinical practice.
Study objective
The primary objective of this study is to explore characteristics (nutritional
status, body composition, and presence of comorbidities) of HD patients related
to successful individual application of bio-electrical impedance to determine
the endpoint of dialysis treatment.
Study design
Exploratory single-centre, observational, cross-sectional study.
Study burden and risks
Bioimpedance is a safe and non-invasive technique. Measurements will be
performed during two separate routine HD treatments and no other procedures
will be performed, which minimises the burden on participants. It is vital that
this study is carried out in actual ESRD patients undergoing routine HD as
bioimpedance measurements have to be taken during HD sessions. Although
participants do not experience direct benefit from participating in this study,
they contribute to the body of knowledge regarding endpoint determination of HD
treatments.
Stippeneng 4
Wageningen 6708WE
NL
Stippeneng 4
Wageningen 6708WE
NL
Listed location countries
Age
Inclusion criteria
ESRD patients undergoing intermittent daytime haemodialysis treatment at Ziekenhuis Gelderse Vallei in Ede
Undergoing routine HD treatment for at least three months
Exclusion criteria
Pacemaker
Metal implants
Major amputations
Pregnancy
Restless legs
Dementia
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 | NL62175.081.17 |