NCT01823484

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 4, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Last Updated

January 15, 2014

Status Verified

January 1, 2014

Enrollment Period

2.3 years

First QC Date

March 19, 2013

Last Update Submit

January 13, 2014

Conditions

Critically IllAcute Kidney InjurySeptic Shock

Keywords

hemofiltercoagulationCRRTcritically ill

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • activated partial thromboplastin time

    every 6h from the begining of continuous renal replacement therapy,up to 72h

Other Outcomes (1)

  • Number of participants with adverse events during continuous renal replacement therapy

    72h

Study Arms (2)

AN 69 ST hemofilter

EXPERIMENTAL

Use AN 69 ST hemofilter during CRRT

Device: AN 69 ST hemofilter

AN 69 hemofilter

ACTIVE COMPARATOR

Use AN 69 hemofilter during CRRT

Device: AN 69 hemofilter

Interventions

AN 69 ST hemofilterDEVICE
AN 69 ST hemofilter
AN 69 hemofilterDEVICE
AN 69 hemofilter

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age\> 18 years old
  • admitted to ICU and need CRRT
  • anticipated survival time \>72h

You may not qualify if:

  • allergy to hemofilter or heparin
  • heparin associated thrombocytopenia
  • pregnancy or lactation
  • using other anticoagulate drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiaohua Qiu

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Critical IllnessAcute Kidney InjuryShock, SepticThrombosis

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSepsisInfectionsSystemic Inflammatory Response SyndromeInflammationShockEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Central Study Contacts

Qiu Xiaohua

CONTACT

02583262553xiaohua0917@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physician

Study Record Dates

First Submitted

March 19, 2013

First Posted

April 4, 2013

Study Start

January 1, 2012

Primary Completion

May 1, 2014

Last Updated

January 15, 2014

Record last verified: 2014-01

Locations

CN(1)