To investigate if determining dry-weight with the assistance of bioelectrical impedance analysis compared to the current practice will result in a better blood pressure control.
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Blood pressure
Secondary outcome
Number of hospital admissions due to fluid overload
Number of additional dialysis sessions due to fluid overload
Number of intradialytic hypotension episodes and/or the number
hypotension-associated dialysis symptoms
Number of antihypertensive drugs
Serum levels of NT-proBNP, albumin and CRP
Cardiovascular related morbidity and mortality
Development of anuria (200 ml/day)
Background summary
Hydration and volume status are important predictors of outcome in patients
with end-stage renal disease on renal replacement therapy. Evaluation of
*euvolemia* untill now is, however, severely hampered by the lack of a reliable
objective tool that can be used to measure volume status in everyday clinical
practice. Multifrequency bioimpedance offers the possibility of evaluating in a
simple way at bedside the body composition and hydration of the patient.
However, evidence is lacking if introduction of this device for routine use in
clinical practice is of benefit for patient outcome.
Study objective
To investigate if determining dry-weight with the assistance of bioelectrical
impedance analysis compared to the current practice will result in a better
blood pressure control.
Study design
Prospective multicentre randomised clinical trial. The patients will be
randomized in two groups. In group 1 bioelectrical impedance analysis will be
leading in the assessment of the dry-weight .In group 2 the assessment of
dry-weight will be performed according to the currently used clinical
parameters. The patients will be followed for 2 years.
Intervention
Measurement of the body composition using Bio-electrical Impendance Analysis
Study burden and risks
There are no additional risks attached to this study. In both groups the chance
exists on the development of dialysis related complications such as hypotensive
episodes. These risks are also present without participation in the study.
Participation in the study will result in a total extra time investment of the
patient of 150 minutes.
Meibergdreef 9
1105AZ Amsterdam
NL
Meibergdreef 9
1105AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Patients must have CKD stage 5 and treatment with hemodialysis or peritoneal dialysis
Exclusion criteria
Heart failure
Expected to receive a living donor transplant within 6 months
Life expectancy less than 6 months
Contraindications for the use of BIA measurements (due to expected measurement errors)
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 | NL37162.018.11 |