Chronic Kidney Disease
Conditions
Interventions
Group 1: Study part A: This study takes place in the context of the follow-up of patients after kidney transplantation. The clinical procedure follows the current guidelines. Contrast-enhanced ultraso
Sponsors
Klinik für Nieren- und Hochdruckkrankheiten, Rheumatologische und Immunologische Erkrankungen, Uniklinik RWTH Aachen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients after kidney transplantation with a GFR = 20 ml/min (study part A) 2. Patients with chronic renal insufficiency with a GFR = 20ml/min (study part B). 3. Written informed consent 4. Persons who are legally competent and mentally capable of following the instructions of the study personnel.
Exclusion criteria
Exclusion criteria: 1. Minority (Underage) 2. Hypersensitivity/allergy to ultrasound contrast agents or their components sulfur hexafluoride, macrogol 4000, colfosceril stearate, 1-(1,2-dipalmitoyl-3-sn-phosphatidyl)glycerol sodium salt palmitic acid 3. Right-to-left shunt 4. Signs of cardiovascular instability, such as recent acute coronary syndrome or clinically unstable ischemic heart disease, evolving or ongoing acute myocardial infarction, typical angina pectoris at rest within the past 7 days, recent coronary interventions (e.g., cardiac catheterization with stent placement), acute heart failure, class III/IV heart failure, severe cardiac arrhythmias. 5. Acute endocarditis 6. Artificial heart valves 7. Acute systemic inflammation and/or sepsis 8. Hypercoagulable state and/or recent thromboembolism 9. End-stage kidney or liver disease 10. Severe pulmonary hypertension (pulmonary arterial pressure > 90 mmHg) 11. Uncontrolled systemic hypertension 12. Acute respiratory distress syndrome 13. Clinically significant lung disease, including severe chronic obstructive pulmonary disease 14. Pregnancy 15. Individuals detained in an institution by government or court order 16. Individuals who have a dependent or employment relationship with the sponsor or investigator 17. Alcohol and substance abuse 18. Expected non-compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of this project is to further develop motion-model ultrasound localisation microscopy (mULM) for clinical renal imaging (study part A) in order to assess the severity of renal function impairment in an exploratory patient study (study part B). | — |
Secondary
| Measure | Time frame |
|---|---|
| Histological assessment of the renal tissue is performed with regard to vessel density and architecture, inflammation of the vessels and texture of the extracellular matrix. This histological data serves as the gold standard and is correlated with ultrasound imaging data. | — |
Countries
Germany
Contacts
Public ContactJürgen Floege
Klinik für Nieren- und Hochdruckkrankheiten, Rheumatologische und Immunologische Erkrankungen, Uniklinik RWTH Aachen
Outcome results
None listed