Cholesterol Embolism
Conditions
Brief summary
The aim of this study is to evaluate efficacy and safety of blood purification therapy on renal dysfunction by cholesterol crystal embolism.
Interventions
DEVICELiposorber LA-15 System
Six sessions of blood purification treatment with Liposorber LA-15 System.
Sponsors
Japan Community Health Care Organization Sendai Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Patients who meet all of the following criteria. * Patients who had cardiac catheterization or vascular surgery in the last 24 weeks before the time of obtaining informed consent. * Patients who satisfy all of the following criteria or are diagnosed as CCE by skin or renal biopsy. 1. Patients with progressive renal dysfunction in the course of weeks or months. 2. Patients with skin lesions such as livedo reticularis of lower extremities or blue toe syndrome. 3. Eosinophil count is more than 400 per microliter. * Patients who or patients whose legal representative understood the requirements of the study and signed the informed consent forms.
Exclusion criteria
Patients who meet any of the following criteria will be excluded. * Patients with contraindication to anticoagulant (Nafamostat Mesilate). * Blood purification therapy is inapplicable because of severe heart failure, acute myocardial infarction, severe arrhythmia, acute stroke, or severe uncontrollable hypertension or hypotension. * Patients with body weight less than 40kg. * Patients with a history of allergic reaction or hypersensitivity to blood purification. * Patients who cannot stop taking ACE inhibitors. * Patients with any disease in which corticosteroid, statin are contraindicated. * Patients participated in another clinical trial or study at the time of obtaining informed consent. * Patients receiving chronic hemodialysis. * Otherwise, patients who are judged by the investigator as being unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of chronic hemodialysis | Six months |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of lower limb amputation | Six months |
| Incidence of gangrene | Six months |
| Dose of drugs | Six months |
| Survival rate | Six months |
| Incidence of adverse events | Six months |
| Incidence of multi organ failure | Six months |
Countries
Japan
Contacts
Primary ContactToshinobu Sato, MD, PhD
Outcome results
None listed