HealthyEGNINCT04363567
Endothelial Glycocalyx in Patients With Chronic Kidney Disease
An observational study of Healthy and Chronic Kidney Diseases, run by Regional Hospital Holstebro.
Trial summary
The luminal side of the entire vasculature is covered with a gel-like polymer called endothelial glycocalyx (EG). EG is important for the transport of molecules in and out of the blood cells and for endothelial function. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Chronic Kidney Diseases
- How many people
- 137 participants
- Where
- No sites listed yet
- Study dates
- 7 Nov 2016to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with chronic kidneys disease in different stages and healthy volunters as control group.
Who may be able to join
- CKD I-V Age> 18 years 4 diabetics in each CKD-class Dialysis patients must have received dialysis for at least 3 months. Signed consent
- Both gender Signed consent
Who cannot join
- Nephrotic syndrome (U-alb> 3.5 g / d, p-alb <30 g / l, and peripheral edema) Alcohol abuse Drug abuse Pregnancy and lactation Hbg <6.2 mmol / l
- Arterial hypertension heart, lung, liver, kidney, endocrine og cerebral diseases alcohol, drug or medical abuse smoking pregnancy or breastfeeding blood-donation within a month clinically significant abnormalities in ECG, blood samples or urine samples
About this study
Official title: Endothelial Glycocalyx Evaluated on Release of the Endothelial Glycocalyx Proteins and Salt Blood Test in Patients With Chronic Kidney Disease
The luminal side of the entire vasculature is covered with a gel-like polymer called endothelial glycocalyx (EG). EG is important for the transport of molecules in and out of the blood cells and for endothelial function. EG protects the blood vessel wall, is likely to contribute to maintenance of normal blood pressure and the prevention of blood clot formation. Overall it is likely to avoid development of cardiovascular disease.
A newly developed blood test, salt-blood test, can measure erythrocyte salt sensitivity and gives information about the condition of EG. EG can also be measured by release of endothelial glycocalyx proteins.
Previous studies indicate that this EG is impaired by a number of chronic diseases, including chronic kidney disease. This study investigates the quality of glycocalyx in patients with chronic kidney disease, and compares with the layer in healthy.
Read the detailed description
The purpose of this study is to gain knowledge about how pronounced the EG are affected in varying degrees of chronic kidney disease compared with healthy controls assessed by
- salt-blood test
- release of endothelial glycocalyx proteins. and to see how this correlates to
- blood pressure (peripheral and central)
- pulse wave velocity
- albuminuria
- coagulation system
- vasoactive hormones (PRC, p-Ang-II, p-Aldo, p-ANP, p-BNP, p-AVP)
- Conditions
- Healthy, Chronic Kidney Diseases
- Keywords
- Salt blood test, endothelial glycocalyx, chronic kidney disease, syndecan-1, heparan sulfate
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CKD 1 | Patients with Chronic kidney disease stage 1: Normal kidney function but urine findings or structural abnormalities or genetic trait point to kidney disease. eGFR :90+. 20 patients, maximun 4 patients with diabetes. | |
| CKD 2 | Patients with Chronic kidney disease stage 2: Mildly reduced kidney function, and other findings (as for stage 1) point to kidney disease. eGFR: 60-89. 20 patients, maximun 4 patients with diabetes. | |
| CKD 3 | Patients with Chronic kidney disease stage 3: Moderately reduced kidney function. eGFR: 30-59. 20 patients, maximun 4 patients with diabetes. | |
| CKD 4 | Patients with Chronic kidney disease stage 4: Severely reduced kidney function. eGFR: 15-29. 20 patients, maximun 4 patients with diabetes. | |
| CKD 5 | Patients with Chronic kidney disease stage 5: Very severe kidney function. eGFR: <15. 20 patients, maximun 4 patients with diabetes. | |
| Dialysis | Patients with end stage renal disease in dialysis. 20 patients, maximun 4 patients with diabetes. | |
| Healthy | 20 healthy people. Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythrocyte Salt Sensitivity
Blood sample
Measured: 1 minute
Secondary outcomes (7)
Syndecan-1
blood sample
Measured: 1 minute
Heparan Sulfate
blood sample
Measured: 1 minute
blood pressure central and peripheral
Mobil-O-Graph
Measured: 1 minute
Vasoactive hormones (PRC, Ang-II, Aldo, ANP, BNP, AVP)
blood samples
Measured: 1 minute
pulse wave velocity
Mobil-O-Graph
Measured: 1 minute
Albuminuria
urine sample
Measured: 1 minute
coagulation
blood samples
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start7 Nov 2016
- Primary completion25 Jun 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regional Hospital Holstebro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesper Norgaard Bech, Regional Hospital Holstebro
- Investigators
- Rikke Lu Sønderbæk, MD, Principal investigator, Department of medical research and medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363567
- Sponsor's protocol ID
- RLS-3-2016
- Acronym
- EGNI
- Status last verified
- Apr 2020
- First submitted
- 23 Apr 2020
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Glycocalyx Evaluated on Release of the Endothelial Glycocalyx Proteins and Salt Blood Test in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04363567
- Acronym / sponsor ID
- EGNI / RLS-3-2016
- Conditions
- Healthy, Chronic Kidney Diseases
- Keywords
- Salt blood test, endothelial glycocalyx, chronic kidney disease, syndecan-1, heparan sulfate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Regional Hospital HolstebroUniversity, hospital or other
- Study start
- 7 Nov 2016 (actual)
- Primary completion
- 25 Jun 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 27 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The luminal side of the entire vasculature is covered with a gel-like polymer called endothelial glycocalyx (EG). EG is important for the transport of molecules in and out of the blood cells and for endothelial function. EG protects the blood vessel wall, is likely to contribute to maintenance of normal blood pressure and the prevention of blood clot formation. Overall it is likely to avoid development of cardiovascular disease.
A newly developed blood test, salt-blood test, can measure erythrocyte salt sensitivity and gives information about the condition of EG. EG can also be measured by release of endothelial glycocalyx proteins.
Previous studies indicate that this EG is impaired by a number of chronic diseases, including chronic kidney disease. This study investigates the quality of glycocalyx in patients with chronic kidney disease, and compares with the layer in healthy.
Detailed description
The purpose of this study is to gain knowledge about how pronounced the EG are affected in varying degrees of chronic kidney disease compared with healthy controls assessed by
- salt-blood test
- release of endothelial glycocalyx proteins. and to see how this correlates to
- blood pressure (peripheral and central)
- pulse wave velocity
- albuminuria
- coagulation system
- vasoactive hormones (PRC, p-Ang-II, p-Aldo, p-ANP, p-BNP, p-AVP)
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| CKD 1 | – | –Patients with Chronic kidney disease stage 1: Normal kidney function but urine findings or structural abnormalities or genetic trait point to kidney disease. eGFR :90+. 20 patients, maximun 4 patients with diabetes. |
| CKD 2 | – | –Patients with Chronic kidney disease stage 2: Mildly reduced kidney function, and other findings (as for stage 1) point to kidney disease. eGFR: 60-89. 20 patients, maximun 4 patients with diabetes. |
| CKD 3 | – | –Patients with Chronic kidney disease stage 3: Moderately reduced kidney function. eGFR: 30-59. 20 patients, maximun 4 patients with diabetes. |
| CKD 4 | – | –Patients with Chronic kidney disease stage 4: Severely reduced kidney function. eGFR: 15-29. 20 patients, maximun 4 patients with diabetes. |
| CKD 5 | – | –Patients with Chronic kidney disease stage 5: Very severe kidney function. eGFR: <15. 20 patients, maximun 4 patients with diabetes. |
| Dialysis | – | –Patients with end stage renal disease in dialysis. 20 patients, maximun 4 patients with diabetes. |
| Healthy | – | –20 healthy people. Control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic kidneys disease in different stages and healthy volunters as control group.
Key inclusion criteria (2 listed)
- CKD I-V Age> 18 years 4 diabetics in each CKD-class Dialysis patients must have received dialysis for at least 3 months. Signed consent
- Both gender Signed consent
Key exclusion criteria (2 listed)
- Nephrotic syndrome (U-alb> 3.5 g / d, p-alb <30 g / l, and peripheral edema) Alcohol abuse Drug abuse Pregnancy and lactation Hbg <6.2 mmol / l
- Arterial hypertension heart, lung, liver, kidney, endocrine og cerebral diseases alcohol, drug or medical abuse smoking pregnancy or breastfeeding blood-donation within a month clinically significant abnormalities in ECG, blood samples or urine samples
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Erythrocyte Salt Sensitivity
Time frame: 1 minute
Blood sample
7 secondary outcomes
Syndecan-1
Time frame: 1 minute
Heparan Sulfate
Time frame: 1 minute
blood pressure central and peripheral
Time frame: 1 minute
Vasoactive hormones (PRC, Ang-II, Aldo, ANP, BNP, AVP)
Time frame: 1 minute
pulse wave velocity
Time frame: 1 minute
Albuminuria
Time frame: 1 minute
coagulation
Time frame: 1 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rikke Lu Sønderbæk, MD principal investigator
Department of medical research and medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Chronic Kidney Diseases, run by Regional Hospital Holstebro.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erythrocyte Salt Sensitivity (time frame: 1 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2020.