nderstanding and monitoring renal microvascular remodeling in CKD by super-resolution ultrasound

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 50

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

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

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

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