Endothelial Glycocalyx in Patients With Chronic Kidney Disease

NCT ID: NCT04363567

Last Updated: 2020-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

137 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-07

Study Completion Date

2019-12-31

Brief Summary

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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

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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)

Conditions

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Healthy Chronic Kidney Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

CKD 3

Patients with Chronic kidney disease stage 3: Moderately reduced kidney function. eGFR: 30-59.

20 patients, maximun 4 patients with diabetes.

No interventions assigned to this group

CKD 4

Patients with Chronic kidney disease stage 4: Severely reduced kidney function. eGFR: 15-29.

20 patients, maximun 4 patients with diabetes.

No interventions assigned to this group

CKD 5

Patients with Chronic kidney disease stage 5: Very severe kidney function. eGFR: \<15.

20 patients, maximun 4 patients with diabetes.

No interventions assigned to this group

Dialysis

Patients with end stage renal disease in dialysis. 20 patients, maximun 4 patients with diabetes.

No interventions assigned to this group

Healthy

20 healthy people. Control group

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Regional Hospital Holstebro

OTHER

Sponsor Role lead

Responsible Party

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Jesper Norgaard Bech

Chief Physician and PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rikke Lu Sønderbæk, MD

Role: PRINCIPAL_INVESTIGATOR

Department of medical research and medicine

Other Identifiers

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RLS-3-2016

Identifier Type: -

Identifier Source: org_study_id

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