Clinical trial NCT02355873: Efficacy and Safety of Heparin-coated Surface-treated Polyacrylonitrile Membrane Hemofilter in Critical Ill CRRT Patients
Official title: Efficacy and Safety of Heparin-coated Surface-treated Polyacrylonitrile Membrane Hemofilter in Critical Ill CRRT Patients Continuous Renal Replacement Therapy Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Critical Ill Patients
Patients Needing Continuous Renal Replacement Therapy
Keywords: heparin-coated
surface-treated polyacrylonitrile membrane hemofilter
critical ill
acute kidney injury
chronic kidney disease
continuous renal replacement therapy
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2015-02-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: ST100 (AN69ST) to M100 (AN69), M100 to ST100
Primary purpose: TREATMENT

Brief summary: CRRT patients are generally critical ill patients with unstable conditions, such as low blood pressure,severe SIRS,et al. Acute kidney injury(AKI)is especially prevalent,with even two or more organ failure. CRRT serves as an important supportive therapy.Continuous anticoagulation is needed to prevent treatment interruptions due to clotting of the extracorporeal circuit. Unfractionated heparin or low molecular weight heparin both increase the risk of bleeding and heparin induced thrombocytopenia in such cases.However, the problem of CRRT without anticoagulation is the early filter clotting. An alternative method is the use of heparin coated hemofilter. The AN69 ST hemofilter, a surface-treated polyacrylonitrile membrane hemofilter, allows irreversible fixing of heparin to filter membrane, is able to reduce thrombogenic properties of the membrane. In this study, we observe the efficacy and safety of heparin-coated AN69 ST hemofilter in CRRT patients, and compare to the original AN69 membrane hemofilter.


Eligibility criteria: Inclusion Criteria:

* Critical ill patients who need continuous renal replacement therapy
* Continuous anticoagulation therapy is not necessarily during CRRT process

Exclusion Criteria:

* Patients needing continuous anticoagulation during each CRRT process
* Expectant survival time less than 72 hours
* Extremely unstable vital signs such as low blood pressure
* Any reasons that resulting in blood flow rate less than 150ml/min
* Pregnant women
* Patients allergic to heparin

Primary outcomes:
measure: The filter survival time of AN69ST and AN69 membrane hemofilter in each CRRT process
timeFrame: 6 months
measure: The number of patients with early filter clotting in the scheduled CRRT using AN69ST and AN69 membrane hemofilter
timeFrame: 6 months
measure: The number of patients in AN69ST and AN69 hemofilter group according to the final filter clotting grading
timeFrame: 6 months
Secondary outcomes:
measure: The number of participants with the adverse events.
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Renal division,department of Medcine,Peking University First Hospital
state: Beijing
Study officials:
References:
citation: Tsujimoto Y, Miki S, Shimada H, Tsujimoto H, Yasuda H, Kataoka Y, Fujii T. Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2021 Sep 14;9(9):CD013330. doi: 10.1002/14651858.CD013330.pub2.
citation: Su T, Jin Q, Liu Z. Polyethyleneimine-treated polyacrylonitrile membrane hemofilter for critically ill patients receiving anticoagulant-free prolonged intermittent renal replacement therapy: a single-center, prospective, self-controlled pilot study. BMC Nephrol. 2017 Jun 30;18(1):208. doi: 10.1186/s12882-017-0627-1.