Acute renal failure, Chronic renal failure
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Aged between 18 and 85 years old (inclusive), regardless of gender. 2.Meeting the indications for continuous renal replacement therapy (CRRT) specified in the 2021 Standard Operating Procedures for Blood Purification, judged by the investigator to require CRRT treatment with a treatment duration of no less than 24 hours. 3.Voluntarily participating in this clinical trial and signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1.History of dialysis allergy or severe allergic constitution (allergic to two or more substances). 2.Planned combined treatment with hemoadsorption, hemoperfusion, ECMO during the trial period. 3.Unable to establish appropriate vascular access due to obvious vascular stenosis, thrombosis or adjacent tissue lesions. 4.Unstable hemodynamic shock during screening, judged unsuitable for enrollment by the investigator. 5.Active bleeding tendency or severe coagulation dysfunction during screening. 6. Planned anticoagulation-free CRRT treatment. 7. Cachexia or malignant tumor with systemic metastasis. 8. Pregnant or lactating females, or those planning pregnancy during the study. 9. Participation in other interventional device clinical trials within 1 month before screening, or within 5 half-lives of the last drug administration in drug clinical trials. 10. Any other condition deemed inappropriate for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-hour creatinine and urea nitrogen clearance rates;24-hour ß2-microglobulin Reduction Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Creatinine and urea nitrogen clearance rates at 24 hours, 48 hours, 72 hours of treatment and at the end of treatment;The clearance rate of ß 2-microglobulin at 2 hours, 24 hours, 48 hours, 72 hours of treatment and at the end of treatment;The decrease rates of creatinine and urea nitrogen at 24 hours of treatment and at the end of treatment;The decline rate of ß 2-microglobulin at the end of treatment;The decline rate of creatinine, urea nitrogen and ß 2-microglobulin clearance rates after 24 hours of treatment compared with 2 hours of treatment;Myoglobin screening coefficients at 2 hours and 24 hours of treatment;The changes of blood gas (PCO2, pH) before treatment, 15 minutes after treatment and at the end of treatment;The changes of blood electrolytes (Na, K, Ca, P, etc.) before and after treatment;Evaluation of device performance;Filter service life; | — |
Countries
China
Contacts
Shanghai Sixth People's Hospital