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

Critical Ill Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02355873
• Other study ID #: 2013QX-FZC-001
• Status: Completed
• Phase: Phase 4
• Start date: February 2015
• Est. completion date: August 2015

Study information

• Verified date: May 2021
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Ill Patients
• Patients Needing Continuous Renal Replacement Therapy

Intervention

Device:
• AN69ST hemofilter

• AN69 hemofilter

Locations

Country	Name	City	State
China	Renal division,department of Medcine,Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The filter survival time of AN69ST and AN69 membrane hemofilter in each CRRT process		6 months
Primary	The number of patients with early filter clotting in the scheduled CRRT using AN69ST and AN69 membrane hemofilter		6 months
Primary	The number of patients in AN69ST and AN69 hemofilter group according to the final filter clotting grading		6 months
Secondary	The number of participants with the adverse events.		6 months