To evaluate the feasibility of TBER-guided ultrafiltration (UF) in patients on HD, using an end-of-HD TBER score of +2 SD as the optimal target.
ID
Source
Brief title
Condition
- Other condition
- Renal disorders (excl nephropathies)
Synonym
Health condition
Afwijkingen in de hydratiestatus van het lichaam ten gevolge van eindstadium nierfalen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Blood pressure, number of intra- and inter-dialytic events, and quality of life.
Secondary outcome
Number and doses of antihypertensive medication and vena cava diameter.
Background summary
Cardiovascular morbidity and mortality are high in patients on hemodialysis
(HD) and this is partially related to suboptimal fluid balance management due
to a lack of accurate tools. During HD, ultrafiltration (UF) is used to remove
the excess fluid that has accumulated in the period between two HD*s. The aim
of UF should be to remove sufficient fluid to prevent overhydration in the
inter-dialytic period, but also to avoid excessive fluid removal that may cause
intra-dialytic events such as hypotension and muscle cramps. This is a very
delicate balance, not well manageable with currently available tools. To date,
fluid management is still based on the dry weight approach, a subjective,
composite target depending on a multitude of clinical variables with limited
accuracy and specificity in defining optimal hydration. We hypothesize that
monitoring of hydration can be improved by measurement of Total Body Electrical
Resistance (TBER) to a 50 kHz alternating current, and the use of a recently
developed method that defines a personalized, TBER-derived hydration normal
range. According to this method a TBER-SD score > +2 reflects dehydration and a
SD score < -2 indicates overhydration. We hypothesize that optimal fluid
management is achieved with an end-of-HD TBER score of +2 SD. A pilot study is
warranted to assess the feasibility of this new approach.
Study objective
To evaluate the feasibility of TBER-guided ultrafiltration (UF) in patients on
HD, using an end-of-HD TBER score of +2 SD as the optimal target.
Study design
Pilot study.
Intervention
Serial measurement of TBER during HD by gel electrodes positioned on hand and
foot to guide UF towards the predicted, patient-specific, TBER target value of
+2 SD at the end of HD.
Study burden and risks
The burden of TBER measurements is nihil. The main burden for participating
patients is the time required to keep diaries, answer questionnaires, and to
undergo non-invasive diagnostic tests. If necessary, patients may receive
prolonged or additional HD sessions. Risks are expected to be not different
from patients treated with conventional HD.
Wagnerlaan 55
Arhem 6815 AD
NL
Wagnerlaan 55
Arhem 6815 AD
NL
Listed location countries
Age
Inclusion criteria
Age > 18 years
On daytime hemodialysis (HD) for * 6 months
Baseline hydration status classified by total body electrical resistance
(TBER):
- Requiring an increase in UF, i.e. post-HD TBER-SD score < +1 SD, or
- Requiring a decrease in UF, i.e. post-HD TBER-SD score > +3 SD
Clinical probability that the patient will be able to complete the trial
successfully
Exclusion criteria
Chronic mental illness
Systolic heart failure
Metallic knee prosthesis on measuring side
Amputated limb on measuring side
Paraplegia or hemiplegia on measuring side
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 | NL70975.091.19 |