Clinical trial NCT04363567: Endothelial Glycocalyx in Patients With Chronic Kidney Disease
Official title: Endothelial Glycocalyx Evaluated on Release of the Endothelial Glycocalyx Proteins and Salt Blood Test in Patients With Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Chronic Kidney Diseases
Keywords: Salt blood test
endothelial glycocalyx
chronic kidney disease
syndecan-1
heparan sulfate
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2020-04-27
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic kidneys disease in different stages and healthy volunters as control group.

Brief 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. 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

1. salt-blood test
2. release of endothelial glycocalyx proteins.

and to see how this correlates to

1. blood pressure (peripheral and central)
2. pulse wave velocity
3. albuminuria
4. coagulation system
5. vasoactive hormones (PRC, p-Ang-II, p-Aldo, p-ANP, p-BNP, p-AVP)

Eligibility criteria: Inclusion Criteria patients with chronic kidney disease:

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

Exclusion Criteria, patients with chronic kidney disease:

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

Inclusion criteria, healthy people:

Both gender Signed consent

Exclusion criteria, healthy people:

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

Primary outcomes:
measure: Erythrocyte Salt Sensitivity
timeFrame: 1 minute
Secondary outcomes:
measure: Syndecan-1
timeFrame: 1 minute
measure: Heparan Sulfate
timeFrame: 1 minute
measure: blood pressure central and peripheral
timeFrame: 1 minute
measure: Vasoactive hormones (PRC, Ang-II, Aldo, ANP, BNP, AVP)
timeFrame: 1 minute
measure: pulse wave velocity
timeFrame: 1 minute
measure: Albuminuria
timeFrame: 1 minute
measure: coagulation
timeFrame: 1 minute
Other outcomes:
Locations:
Study officials:
affiliation: Department of medical research and medicine
name: Rikke Lu Sønderbæk, MD
role: PRINCIPAL_INVESTIGATOR
References: