Main objectives: 1 Perform regression and correlation analysis on urea concentrations in sweat/saliva versus blood at the start of hemodialysis (C0), at the end of hemodialysis (Ct) and on the ratio (Ct/C0). 2 Feasibility of sweat and/or saliva…
ID
Source
Brief title
Condition
- Nephropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Endpoints:
- Correlation coefficients and bias between urea concentration in plasma, sweat
and saliva at the start (C0) and at the end (Ct) of hemodialysis and as a ratio
(Ct/C0).
- (Difference between) Kt/V values determined with urea concentrations in
plasma, sweat and saliva
- (Statistical difference between) the coefficients of the estimated
curves for urea concentrations in saliva versus plasma during hemodialysis
Parameters:
- Urea concentrations in plasma, sweat and saliva at the start (C0) and at the
end (Ct) of the hemodialysis
- To calculate the Kt/V: ratio of urea concentrations (Ct/C0), time of
hemodialysis (T), intradialytic body weight loss (dBW) and the body weight at
the end of dialysis (BW)(formula 1).
- Salivary and plasma urea concentrations at four time points during
hemodialysis.
Secondary outcome
Endpoint:
- Correlation coefficients and bias between creatinine concentration in plasma,
sweat and saliva at the start (C0) and at the end (Ct) of hemodialysis and as a
ratio (Ct/C0).
- (Statistical difference between) the coefficients of the estimated
curves for creatinine concentrations in saliva versus plasma during
hemodialysis.
Parameters:
- Creatinine concentrations in plasma, sweat and saliva at the start (C0)
and at the end (Ct) of the hemodialysis
- Salivary and plasma creatinine concentration at four time-points for
saliva and blood during hemodialysis.
Background summary
Hemodialysis supports renal clearance by dialysis of the patients* blood. This
is a time consuming treatment with 4 hour cycles, up to five sessions per week.
Each patient is monitored using laboratory analysis. Plasma urea concentrations
before and after the treatment are used to calculate the dialysis adequacy.
The development of sensors able to measure low volume bio-fluids makes sweat
sensing an emerging technology for non-invasive and continuous analyte
monitoring. In hemodialysis patients, a sweat sensor that is able to measure
the urea concentration could potentially be used to non-invasively and
continuously monitor the treatment adequacy.
Next to sweat sensing, analysis of the urea concentration in saliva could be an
alternative non-invasive method to monitor hemodialysis adequacy.
This study establishes the correlation between urea concentrations determined
in blood, sweat and saliva in hemodialysis patients. It should be considered a
pilot study to provide insight in the feasibility of sweat and saliva analysis
for monitoring hemodialysis adequacy.
Study objective
Main objectives:
1 Perform regression and correlation analysis on urea concentrations in
sweat/saliva versus blood at the start of hemodialysis (C0), at the end of
hemodialysis (Ct) and on the ratio (Ct/C0).
2 Feasibility of sweat and/or saliva analysis to determine the hemodialysis
adequacy
3 To obtain more knowledge about the kinetics of salivary urea
concentrations during hemodialysis.
Secundary objective:
• Perform regression and correlation analysis on creatinine concentrations in
sweat/saliva versus blood at the start of hemodialysis (C0), at the end (Ct)
and on the ratio (Ct/C0).
• To obtain more knowledge about the kinetics of salivary creatinine
concentrations during hemodialysis.
Study design
This study can be classified as a non-therapeutic single-center cohort study
(WMO plichtig).During routine hemodialysis treatment in the hospital, a sweat,
saliva and blood sample will be collected at the beginning and the end of the
treatment. Two additional saliva and plasma samples will be collected during
hemodialysis. The samples are collected during treatment, therefor the
study-procedure will not elongate the hospital stay
Study burden and risks
There is no extra risk or burden associated with participation. Sweat
stimulation and collection will be done by a validated method that is also used
in routine practice. This method is based on pilocarpine iontophoresis with the
Macroduct® Advanced Sweat collection system 3700/3710 (CE marked) according to
manufacturer*s instructions. During the stimulation of the sweat, the patient
might experience a tinkling or slightly irritating feeling on the place of
stimulation on the under arm, this should not be painful. There will be four
blood draw moments per patient, with 2x 5 tubes and 2x 3 tubes per draw. Saliva
collection is non-invasive. The risk and burden for the patients during this
study are minimal.
Michelangelolaan 2
Eindhoven 5823 EJ
NL
Michelangelolaan 2
Eindhoven 5823 EJ
NL
Listed location countries
Age
Inclusion criteria
The patient is treated with hemodialysis
Exclusion criteria
- Age below 18 years old
- Hospitalization for any reason other than hemodialysis treatment
- Patients with an implanted device, such as a defibrillator, neurostimulator,
pacemaker, or ECG monitor.
- Patients with a history of epilepsy or seizures.
- Patients who are pregnant.
- Patients that have a known sensitivity or allergy to any used ingredient.
- Over damaged, denuded skin or other recent scar tissue.
- Patients with Cardiac Conditions or with suspected heart problems.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL77434.100.21 |
| OMON | NL-OMON23387 |