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Completed

NCT Number: NCT04363567

Endothelial Glycocalyx 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.

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Key information

Conditions

Healthy Chronic Disease Chronic Kidney Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Erythrocyte Salt Sensitivity

    Time frame: 1 minute

    Blood sample

Secondary outcomes

  1. Syndecan-1

    Time frame: 1 minute

    blood sample

  2. Heparan Sulfate

    Time frame: 1 minute

    blood sample

  3. blood pressure central and peripheral

    Time frame: 1 minute

    Mobil-O-Graph

  4. Vasoactive hormones (PRC, Ang-II, Aldo, ANP, BNP, AVP)

    Time frame: 1 minute

    blood samples

  5. pulse wave velocity

    Time frame: 1 minute

    Mobil-O-Graph

  6. Albuminuria

    Time frame: 1 minute

    urine sample

  7. coagulation

    Time frame: 1 minute

    blood samples

Sponsors and collaborators

Lead sponsor

Regional Hospital Holstebro

Other

Registry information

Official study title

Endothelial Glycocalyx Evaluated on Release of the Endothelial Glycocalyx Proteins and Salt Blood Test in Patients With Chronic Kidney Disease

Acronym: EGNI

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 27, 2020
Registry last updated
Apr 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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