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ID
Source
Brief title
Health condition
End stage chronic kidney diseases
Sponsors and support
Catharina Onderzoeksfonds
Intervention
Outcome measures
Primary outcome
The endpoints for the first objective are the correlation coefficients and the bias of urea concentrations in sweat and saliva versus blood, that will be determined with the Bland-Altman method. Possible confounding factors will be analyzed. The endpoint for feasibility (the second objective) is the correspondence of the Kt/V determined in sweat and saliva to the Kt/V determined in plasma. To analyze the correspondence of Kt/V, Bland Altman analysis will be used to establish bias and variation and to assess this data with the critical difference of plasma Kt/V obtained from experts.
Secondary outcome
Correlation coefficients and the bias of creatinine concentrations in sweat and saliva versus blood.
Background summary
Rationale:
Hemodialysis supports renal clearance by dialysis of the patients’ blood. This is a time
consuming treatment with 4 hour cycles, three 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.
Primary 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
Secondary objective:
1. Perform regression and correlation analysis on creatinine concentrations in sweat/saliva
versus blood at the start of hemodialysis (C0), at the end of hemodialysis (Ct) and on the
ratio (Ct/C0).
Study design: non-therapeutic single-center cohort study (WMO-plichtig)
Study population: 40 hemodialysis patients at the Catharina Hospital Eindhoven
Study objective
There is a relation between urea concentrations in blood, sweat and saliva, such that sweat and saliva can be used to non-invasively and continuously monitor hemodialysis adequacy.
Study design
Two timepoints at one hemodialysis session
Intervention
Sweat, saliva and blood will be obtained twice during one hemodialysis session: one time at the start and the other time at the end of the hemodialysis session.
Inclusion criteria
- Patient is being treated with hemodialysis in the Catharina Hospital Eindhoven
Exclusion criteria
- <18 years
- 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
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9831 |
| CCMO | NL77434.100.21 |
| OMON | NL-OMON51983 |