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Endothelial Glycocalyx in Patients With Chronic Kidney Disease (EGNI)

R

Regional Hospital Holstebro

Status

Completed

Conditions

Chronic Kidney Diseases
Healthy

Study type

Observational

Funder types

Other

Identifiers

NCT04363567
RLS-3-2016

Details and patient eligibility

About

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.

Full 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)

Enrollment

137 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

137 participants in 7 patient groups

CKD 1
Description:
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
Description:
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
Description:
Patients with Chronic kidney disease stage 3: Moderately reduced kidney function. eGFR: 30-59. 20 patients, maximun 4 patients with diabetes.
CKD 4
Description:
Patients with Chronic kidney disease stage 4: Severely reduced kidney function. eGFR: 15-29. 20 patients, maximun 4 patients with diabetes.
CKD 5
Description:
Patients with Chronic kidney disease stage 5: Very severe kidney function. eGFR: \<15. 20 patients, maximun 4 patients with diabetes.
Dialysis
Description:
Patients with end stage renal disease in dialysis. 20 patients, maximun 4 patients with diabetes.
Healthy
Description:
20 healthy people. Control group

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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