search
Back to results

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

Primary Purpose

Critically Ill, Acute Kidney Injury, Septic Shock

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
AN 69 ST hemofilter
AN 69 hemofilter
Sponsored by
Zhongda Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critically Ill focused on measuring hemofilter, coagulation, CRRT, critically ill

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Xiaohua QiuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AN 69 ST hemofilter

AN 69 hemofilter

Arm Description

Use AN 69 ST hemofilter during CRRT

Use AN 69 hemofilter during CRRT

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

activated partial thromboplastin time
Heparin will be used according to activated partial thromboplastin time, and the quantity will be recorded.

Full Information

First Posted
March 19, 2013
Last Updated
January 13, 2014
Sponsor
Zhongda Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01823484
Brief Title
Effects of AN69 ST Hemofilter on Coagulation During Continuous Renal Replacement Therapy in Critically Ill
Official Title
Effects of AN69 ST Hemofilter on Coagulation During Continuous Renal Replacement Therapy in Critically Ill
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongda Hospital

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill, Acute Kidney Injury, Septic Shock
Keywords
hemofilter, coagulation, CRRT, critically ill

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AN 69 ST hemofilter
Arm Type
Experimental
Arm Description
Use AN 69 ST hemofilter during CRRT
Arm Title
AN 69 hemofilter
Arm Type
Active Comparator
Arm Description
Use AN 69 hemofilter during CRRT
Intervention Type
Device
Intervention Name(s)
AN 69 ST hemofilter
Intervention Type
Device
Intervention Name(s)
AN 69 hemofilter
Primary Outcome Measure Information:
Title
The using time of hemofilters
Description
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
Time Frame
72h
Secondary Outcome Measure Information:
Title
activated partial thromboplastin time
Description
Heparin will be used according to activated partial thromboplastin time, and the quantity will be recorded.
Time Frame
every 6h from the begining of continuous renal replacement therapy,up to 72h
Other Pre-specified Outcome Measures:
Title
Number of participants with adverse events during continuous renal replacement therapy
Time Frame
72h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiu Xiaohua
Phone
02583262553
Email
xiaohua0917@163.com
Facility Information:
Facility Name
Xiaohua Qiu
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiu Xiaohua
Phone
02583262553
Email
xiaohua0917@163.com
First Name & Middle Initial & Last Name & Degree
Qiu Xiaohua

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs