Critically IllNCT01823484
Effects of AN69 ST Hemofilter on Coagulation During Continuous Renal Replacement Therapy in Critically Ill
A study testing AN 69 ST hemofilter and AN 69 hemofilter in people with Critically Ill and Acute Kidney Injury, run by Zhongda Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Critically Ill, Acute Kidney Injury, Septic Shock
- What is being tested?
- AN 69 ST hemofilter and AN 69 hemofilter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age> 18 years old
- admitted to ICU and need CRRT
- anticipated survival time >72h
Who cannot join
- allergy to hemofilter or heparin
- heparin associated thrombocytopenia
- pregnancy or lactation
- using other anticoagulate drugs
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiaohua Qiu
Nanjing, Jiangsu, 210009
Qiu Xiaohua, 02583262553, xiaohua0917@163.com
Qiu Xiaohua
About this study
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.
- Conditions
- Critically Ill, Acute Kidney Injury, Septic Shock
- Being tested
- AN 69 ST hemofilter, AN 69 hemofilter
- Keywords
- hemofilter, coagulation, CRRT, critically ill
- Medical subject headings
- Critical Illness, Acute Kidney Injury, Shock, Septic, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AN 69 ST hemofilterDevice
AN 69 hemofilterDevice
| Study group | Role | What they receive |
|---|---|---|
| AN 69 ST hemofilter | Experimental | Use AN 69 ST hemofilter during CRRT Receives: Device: AN 69 ST hemofilter |
| AN 69 hemofilter | Active comparator | Use AN 69 hemofilter during CRRT Receives: Device: AN 69 hemofilter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 72h
Secondary outcomes (1)
activated partial thromboplastin time
Heparin will be used according to activated partial thromboplastin time, and the quantity will be recorded.
Measured: every 6h from the begining of continuous renal replacement therapy,up to 72h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startJan 2012
- Primary completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaohua Qiu, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823484
- Sponsor's protocol ID
- 112233
- Status last verified
- Jan 2014
- First submitted
- 19 Mar 2013
- Last updated
- 15 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of AN69 ST Hemofilter on Coagulation During Continuous Renal Replacement Therapy in Critically Ill
- ClinicalTrials.gov ID
- NCT01823484
- Acronym / sponsor ID
- 112233
- Conditions
- Critically Ill, Acute Kidney Injury, Septic Shock
- Keywords
- hemofilter, coagulation, CRRT, critically ill
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2014 (estimated)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AN 69 ST hemofilter | Experimental | Device: AN 69 ST hemofilterUse AN 69 ST hemofilter during CRRT |
| AN 69 hemofilter | Active comparator | Device: AN 69 hemofilterUse AN 69 hemofilter during CRRT |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age> 18 years old
- admitted to ICU and need CRRT
- anticipated survival time >72h
Key exclusion criteria (4 listed)
- allergy to hemofilter or heparin
- heparin associated thrombocytopenia
- pregnancy or lactation
- using other anticoagulate drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AN 69 ST hemofilter | Device | AN 69 ST hemofilter |
| AN 69 hemofilter | Device | AN 69 hemofilter |
Primary outcome
The using time of hemofilters
Time frame: 72h
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
1 secondary outcome
activated partial thromboplastin time
Time frame: every 6h from the begining of continuous renal replacement therapy,up to 72h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AN 69 ST hemofilter and AN 69 hemofilter in people with Critically Ill and Acute Kidney Injury, run by Zhongda Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiu Xiaohua (02583262553, xiaohua0917@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The using time of hemofilters (time frame: 72h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2014.