Efficacy and Safety of Heparin-coated Surface-treated Polyacrylonitrile Membrane Hemofilter in Critical Ill CRRT Patients

NCT ID: NCT02355873

Last Updated: 2021-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-08-31

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.

Conditions

Critical Ill Patients; Patients Needing Continuous Renal Replacement Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

AN69ST

AN69ST:Surface-treated Polyacrylonitrile Membrane Hemofilter

Group Type: EXPERIMENTAL

AN69ST hemofilter

Intervention Type: DEVICE

AN69

AN69:original Polyacrylonitrile Membrane Hemofilter

Group Type: ACTIVE_COMPARATOR

AN69 hemofilter

Intervention Type: DEVICE

Interventions

AN69ST hemofilter

Intervention Type: DEVICE

AN69 hemofilter

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tao Su

Effect of heparin coated Surface-treated Polyacrylonitrile Membrane Hemofilter in Critical Ill CRRT Patients

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Renal division,department of Medcine,Peking University First Hospital

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 34519356 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28666474 (View on PubMed)

Other Identifiers

2013QX-FZC-001

Identifier Type: -

Identifier Source: org_study_id