Adults Receiving Renal Replacement TherapyBEERTNCT01560364
Bundle Evaluation in Extra Renal Epuration, Incidence of Thrombosis
An observational study of Adults Receiving Renal Replacement Therapy, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
This is a prospective observational clinical multicentric study in ICU with acute renal failure requiring renal replacement therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adults Receiving Renal Replacement Therapy
- What is being tested?
- renal replacement therapy
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- May 2011to Aug 2012
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults receiving renal replacement therapy
Who may be able to join
- Adult (age > 18 years)
- Renal replacement therapy (continuous veino-veinous hemofiltration or continuous veino-veinous hemodiafiltration)
- Consent of patients
Who cannot join
- Use citrate anticoagulation
- Age below 18 years
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective observational clinical multicentric study in ICU with acute renal failure requiring renal replacement therapy.
Read the detailed description
Prospective before / after observational clinical multicentric study on ICU acute kidney injury during renal replacement therapy. Evaluation of incidence and exposure to hemofilter clotting.
The after phase will consist in medical measures (help for prescription) and paramedical measures (stop the filtration flow during the patient's mobilization).
- Being tested
- renal replacement therapy
- Keywords
- Renal replacement therapy, Hemofilter clotting, Clotting risk factor, Hemofilter clotting prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal replacement therapyOther
Prospective observational clinical multicentric study in ICU with acute renal failure requiring renal replacement therapy.
| Study group | Role | What they receive |
|---|---|---|
| Hemofilter | Not described Receives: Other: renal replacement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemofilter lifetime
Measured: at day 1
Secondary outcomes (3)
Hemofilter clotting risk factors
Measured: at day 1
hemofiltration duration
Measured: at day 1
down time value
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startMay 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adults Receiving Renal Replacement TherapyStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien PERBET, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560364
- Sponsor's protocol ID
- CHU-0106
- Acronym
- BEERT
- Status last verified
- Nov 2014
- First submitted
- 17 Oct 2011
- Last updated
- 2 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bundle Evaluation in Extra Renal Epuration, Incidence of Thrombosis
- ClinicalTrials.gov ID
- NCT01560364
- Acronym / sponsor ID
- BEERT / CHU-0106
- Keywords
- Renal replacement therapy, Hemofilter clotting, Clotting risk factor, Hemofilter clotting prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 22 Mar 2012 (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.
This is a prospective observational clinical multicentric study in ICU with acute renal failure requiring renal replacement therapy.
Detailed description
Prospective before / after observational clinical multicentric study on ICU acute kidney injury during renal replacement therapy. Evaluation of incidence and exposure to hemofilter clotting.
The after phase will consist in medical measures (help for prescription) and paramedical measures (stop the filtration flow during the patient's mobilization).
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemofilter | – | Other: renal replacement therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults receiving renal replacement therapy
Key inclusion criteria (3 listed)
- Adult (age > 18 years)
- Renal replacement therapy (continuous veino-veinous hemofiltration or continuous veino-veinous hemodiafiltration)
- Consent of patients
Key exclusion criteria (2 listed)
- Use citrate anticoagulation
- Age below 18 years
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 |
|---|---|---|
| renal replacement therapyProspective observational clinical multicentric study in ICU with acute renal failure requiring renal replacement therapy. | Other | Hemofilter |
Primary outcome
Hemofilter lifetime
Time frame: at day 1
3 secondary outcomes
Hemofilter clotting risk factors
Time frame: at day 1
hemofiltration duration
Time frame: at day 1
down time value
Time frame: at day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
Related trials for Adults Receiving Renal Replacement Therapy
Not yet recruitingObservational study
Frailty and Outcomes in Critically Ill Patients Receiving CRRT
Acute Kidney Injury
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.
Sébastien PERBET principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adults Receiving Renal Replacement Therapy, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 2 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: finished, as of the sponsor's last update on 2 Dec 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemofilter lifetime (time frame: at day 1). 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 2 Dec 2014.