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A prospective, multicenter, randomized, open-label, parallel-controlled clinical trial to evaluate the safety and efficacy of continuous hemodiafilter in continuous renal replacement therapy

A prospective, multicenter, randomized, open-label, parallel-controlled clinical trial to evaluate the safety and efficacy of continuous hemodiafilter in continuous renal replacement therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125873
Enrollment
Unknown
Registered
2026-06-01
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute renal failure, Chronic renal failure

Interventions

Experimental group:Perform treatment with a continuous hemodiafilter
Control group:Treatment using hollow-fiber hemodiafilter

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

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

MeasureTime frame
2-hour creatinine and urea nitrogen clearance rates;24-hour ß2-microglobulin Reduction Rate;

Secondary

MeasureTime 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

Public ContactWang Niansong

Shanghai Sixth People's Hospital

Wangniansong2012@126.com+86 189 3017 7399

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026