Endothelial Glycocalyx in Patients With Chronic Kidney Disease

NCT04363567 | Completed

• 1 other identifier: RLS-3-2016
• Study Type: observational
• Target: 137
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy; Chronic Kidney Diseases

Keywords

Salt blood test; endothelial glycocalyx; chronic kidney disease; syndecan-1; heparan sulfate

Outcome Measures

Primary Outcomes (1)

• Erythrocyte Salt Sensitivity

  Blood sample

  1 minute

Secondary Outcomes (7)

• Syndecan-1

  1 minute

• Heparan Sulfate

  1 minute

• blood pressure central and peripheral

  1 minute

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

  1 minute

• pulse wave velocity

  1 minute

Study Arms (7)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with chronic kidneys disease in different stages and healthy volunters as control group.

You may qualify if:

• 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

You may not qualify if:

• 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
• Both gender Signed consent
• 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

Sponsors & Collaborators

• Regional Hospital Holstebro: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Rikke Lu Sønderbæk, MD

  Department of medical research and medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician and PhD

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 27, 2020
• Study Start: November 7, 2016
• Primary Completion: June 25, 2019
• Study Completion: December 1, 2019
• Last Updated: April 27, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share