Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 11:09 PM
Study NCT ID:
NCT04363567
Status:
COMPLETED
Last Update Posted:
2020-04-27
First Post:
2020-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endothelial Glycocalyx in Patients With Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-23', 'studyFirstSubmitDate': '2020-04-23', 'studyFirstSubmitQcDate': '2020-04-23', 'lastUpdatePostDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Erythrocyte Salt Sensitivity', 'timeFrame': '1 minute', 'description': 'Blood sample'}], 'secondaryOutcomes': [{'measure': 'Syndecan-1', 'timeFrame': '1 minute', 'description': 'blood sample'}, {'measure': 'Heparan Sulfate', 'timeFrame': '1 minute', 'description': 'blood sample'}, {'measure': 'blood pressure central and peripheral', 'timeFrame': '1 minute', 'description': 'Mobil-O-Graph'}, {'measure': 'Vasoactive hormones (PRC, Ang-II, Aldo, ANP, BNP, AVP)', 'timeFrame': '1 minute', 'description': 'blood samples'}, {'measure': 'pulse wave velocity', 'timeFrame': '1 minute', 'description': 'Mobil-O-Graph'}, {'measure': 'Albuminuria', 'timeFrame': '1 minute', 'description': 'urine sample'}, {'measure': 'coagulation', 'timeFrame': '1 minute', 'description': 'blood samples'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Salt blood test', 'endothelial glycocalyx', 'chronic kidney disease', 'syndecan-1', 'heparan sulfate'], 'conditions': ['Healthy', 'Chronic Kidney Diseases']}, 'descriptionModule': {'briefSummary': '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.\n\nA 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.\n\nPrevious 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.', 'detailedDescription': '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\n\n1. salt-blood test\n2. release of endothelial glycocalyx proteins.\n\nand to see how this correlates to\n\n1. blood pressure (peripheral and central)\n2. pulse wave velocity\n3. albuminuria\n4. coagulation system\n5. vasoactive hormones (PRC, p-Ang-II, p-Aldo, p-ANP, p-BNP, p-AVP)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic kidneys disease in different stages and healthy volunters as control group.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria patients with chronic kidney disease:\n\nCKD I-V Age\\> 18 years 4 diabetics in each CKD-class Dialysis patients must have received dialysis for at least 3 months. Signed consent\n\nExclusion Criteria, patients with chronic kidney disease:\n\nNephrotic 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\n\nInclusion criteria, healthy people:\n\nBoth gender Signed consent\n\nExclusion criteria, healthy people:\n\nArterial 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'}, 'identificationModule': {'nctId': 'NCT04363567', 'acronym': 'EGNI', 'briefTitle': 'Endothelial Glycocalyx in Patients With Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Regional Hospital Holstebro'}, 'officialTitle': 'Endothelial Glycocalyx Evaluated on Release of the Endothelial Glycocalyx Proteins and Salt Blood Test in Patients With Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'RLS-3-2016'}}, 'armsInterventionsModule': {'armGroups': [{'label': '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+.\n\n20 patients, maximun 4 patients with diabetes.'}, {'label': '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.\n\n20 patients, maximun 4 patients with diabetes.'}, {'label': 'CKD 3', 'description': 'Patients with Chronic kidney disease stage 3: Moderately reduced kidney function. eGFR: 30-59.\n\n20 patients, maximun 4 patients with diabetes.'}, {'label': 'CKD 4', 'description': 'Patients with Chronic kidney disease stage 4: Severely reduced kidney function. eGFR: 15-29.\n\n20 patients, maximun 4 patients with diabetes.'}, {'label': 'CKD 5', 'description': 'Patients with Chronic kidney disease stage 5: Very severe kidney function. eGFR: \\<15.\n\n20 patients, maximun 4 patients with diabetes.'}, {'label': 'Dialysis', 'description': 'Patients with end stage renal disease in dialysis. 20 patients, maximun 4 patients with diabetes.'}, {'label': 'Healthy', 'description': '20 healthy people. Control group'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Rikke Lu Sønderbæk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of medical research and medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regional Hospital Holstebro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician and PhD', 'investigatorFullName': 'Jesper Norgaard Bech', 'investigatorAffiliation': 'Regional Hospital Holstebro'}}}}