Effects of AN69 ST Hemofilter on Coagulation During Continuous Renal Replacement Therapy in Critically Ill

Acute Kidney Injury Clinical Trial

Official title:

Effects of AN69 ST Hemofilter on Coagulation During Continuous Renal Replacement Therapy in Critically Ill

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01823484
• Other study ID #: 112233
• Status: Recruiting
• Phase: N/A
• First received: March 19, 2013
• Last updated: January 13, 2014
• Start date: January 2012

Study information

• Verified date: January 2014
• Source: Zhongda Hospital
• Contact: Qiu Xiaohua
• Phone: 02583262553
• Email: xiaohua0917[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Compared with AN69 hemofilter, AN69 ST hemofilter may prolong the time of hemofilter and decrease the quantity of heparin during continuous renal replacement therapy in critically ill.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• age> 18 years old

• admitted to ICU and need CRRT

• anticipated survival time >72h

Exclusion Criteria:

• allergy to hemofilter or heparin

• heparin associated thrombocytopenia

• pregnancy or lactation

• using other anticoagulate drugs

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury
• Critical Illness
• Critically Ill
• Septic Shock

Intervention

Device:
• AN 69 ST hemofilter

• AN 69 hemofilter

Locations

Country	Name	City	State
China	Xiaohua Qiu	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with adverse events during continuous renal replacement therapy		72h	Yes
Primary	The using time of hemofilters	The time from the beginning of continuous renal replacement therapy until to the end when continuous renal replacement therapy had to be finished because of clotting or other reasons	72h	No
Secondary	activated partial thromboplastin time	Heparin will be used according to activated partial thromboplastin time, and the quantity will be recorded.	every 6h from the begining of continuous renal replacement therapy,up to 72h	No