To determine if a marked change in the concentrations of one or more of the selected biomarker is evident before PUs are visible
ID
Source
Brief title
Condition
- Other condition
- Spinal cord and nerve root disorders
Synonym
Health condition
Decubitus
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The concentration of several biomarkers in urine.
Secondary outcome
To determine possible causes for changes in biomarker concentration not
associated with a PU.
Background summary
Individuals with a spinal cord injury are at high risk for developing a
pressure ulcer (PU) due to immobility and lack of sensation. The first step in
treating PUs is pressure relieve, which can lead to the patient becoming
bedbound. It is hypothesized that due to degradation of soft tissue (e.g. skin,
muscle) several biomarkers are released into the bloodstream and subsequently
excreted in urine before the PU is visible. These markers can be used in an
early detection method aimed at earlier treatment of PUs. The first step in
this method is non-invasively screening high risk individuals. If an indication
of PU development is made further diagnostics (e.g. MRI, ultrasound) should
identify the area at risk. The aim of this study is to determine the
suitability of several biomarkers for monitoring PUs. Normal values of the
markers in urine are currently unknown for individuals with a spinal cord
injury (SCI). An exploratory study will be performed to ascertain baseline
variability. An extended study will be performed to determine changes in
biomarker concentration before PUs are visible.
Study objective
To determine if a marked change in the concentrations of one or more of the
selected biomarker is evident before PUs are visible
Study design
A prospective cohort study
Study burden and risks
At the start of the exploratory study an initial interview will be held with
the participants. A pin prick will be collected to exclude patients with an
active infection. Over a period of 8 weeks participants will collect daily
morning urine samples and fill in a questionnaire. The risks associated with
blood sampling are minimal.
At the start of the extended study an initial interview will be held with the
participants. Over a maximal period of 2 years participants will fill in a
questionnaire and collect a urine sample every 4 weeks. Development of a PU
(excluding category I) necessitates daily urine sampling and daily submitting
of a questionnaire for a week, after which the study will end. Unexplainable
fever, indicative for deep tissue injury, necessitates daily urine sampling and
daily submitting of a questionnaire until the cause of the fever is determined,
the fever has resolved or a pressure ulcer is detected. The extended study has
no risks. The participants are mainly burdened by the time it takes to fill in
the questionnaire, collect the urine samples and hand in the urine sample
Groene Loper 15
Eindhoven 5612AP
NL
Groene Loper 15
Eindhoven 5612AP
NL
Listed location countries
Age
Inclusion criteria
Group 1
* Adult
* Have a sensory and motor complete lesion, ASIA A between L1 and C4
* Lesion acquired less than 1 year ago
* Possible to collect a non-contaminated urine sample (e.g. naturally controlled urination, clean intermittent catheterisation, indwelling catheter with a sample port)
* Signed informed consent ;Group 2+4
* Adult
* Have a sensory and motor complete lesion, ASIA A between L1 and C4
* Lesion acquired over 1 year ago.
* Possible to collect a non-contaminated urine sample (e.g. naturally controlled urination, clean intermittent catheterisation, indwelling catheter with a sample port)
* Signed informed consent ;Group 3
* Adult
* In good health
* Signed informed consent
Exclusion criteria
All groups
* Mental disability that hinders the ability to understand and comply with the informed consent
* Diagnosed skin disease
* Oncological patients
* If a subject is unable to obtain urine samples themselves and do not have assistance.
* Fever (temperature > 38*C) will lead to temporary exclusion
* Have had a pressure ulcers diagnosed in the past 6 months.;Extra exclusion criteria for group 1+2+3
* Active infections at the start of the study (determined by POCT CRP) will lead to temporary exclusion
* If a subject in the home situation does not have the ability to store samples at minus 20*C.
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 | NL52521.060.15 |