Acute Renal FailureNCT00993733
Assessing the Impact of Two Methods of Continuous Veno-venous Hemodiafiltration on Time Nursing Work in Intensive Care
A study testing Continuous veno-venous haemodiafiltration in people with Acute Renal Failure, run by Centre Hospitalier Universitaire de Saint Etienne.
Trial summary
The prevalence of acute renal failure in intensive care is estimated at between 5 and 20% depending on diagnostic criteria retained. And half of patients require the use of hemodialysis. Continuous veno-venous hemodiafiltration (CVVHDF) is one of the hemodialysis technique widely used in intensive care unit. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Renal Failure
- What is being tested?
- Continuous veno-venous haemodiafiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Sep 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient affiliated with or beneficiary of a social security category
- Patient with a renal failure requiring a CVVHDF for at least 2 cycles of 12 hours
Who cannot join
- N/A
About this study
The prevalence of acute renal failure in intensive care is estimated at between 5 and 20% depending on diagnostic criteria retained. And half of patients require the use of hemodialysis. Continuous veno-venous hemodiafiltration (CVVHDF) is one of the hemodialysis technique widely used in intensive care unit.
The CVVHDF is performed at the bedside, by a mobile generator with a semi permeable membrane, a blood circuit, a dialysate circuit and a feedback circuit.
Read more
The implementation of a CVVHDF requires the use of large amounts of biological liquid essential to enable the purification of blood during its passage through the artificial kidney.
The objective of this study is to assess time nursing work and the costs of each method.
Read the detailed description
The prevalence of acute renal failure in intensive care is estimated at between 5 and 20% depending on diagnostic criteria retained. And half of patients require the use of hemodialysis. Continuous veno-venous hemodiafiltration (CVVHDF) is one of the hemodialysis technique widely used in intensive care unit.
The CVVHDF is performed at the bedside, by a mobile generator with a semi permeable membrane, a blood circuit, a dialysate circuit and a feedback circuit.
The implementation of a CVVHDF requires the use of large amounts of biological liquid essential to enable the purification of blood during its passage through the artificial kidney. The biological fluid may be supplied to the generator of CVVHDF in 2 ways:
- The conventional method, the most used: the generator operates with pockets containing dialysis fluid, these pockets to be changed regularly by nurses
- The on-line method: the generator operates with a specific water system supplying the dialysis fluid available in every room of the unit The objective of this study is to assess time nursing work and the costs of each method.
For this, 15 patients will be included in this study. Each patient performs 12 hours of each method (conventional and online), whose order will be randomized.
- Conditions
- Acute Renal Failure
- Being tested
- Continuous veno-venous haemodiafiltration
- Keywords
- hemodiafiltration, cost, dialysis solution, acute renal failure, intensive care unit
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous veno-venous haemodiafiltrationProcedure or surgery
Also called Classical CVVHDF : dialusate generator Prismaflex (HOSPAL), CVVHDF on-line : dialysate generator 5008 (Fresenius)
Dialysis procedure administrated to the patients with acute renal failure
| Study group | Role | What they receive |
|---|---|---|
| CVVHDF on-line | Experimental | CVVHDF using a central water treatment plant, providing dialysate directly to the patient. They will perform a continuous veno-venous haemodiafiltration. Receives: Procedure: Continuous veno-venous haemodiafiltration |
| classical CVVHDF | Experimental | CVVHDF using a mobile generator with dialysate bags. They will perform a continuous veno-venous haemodiafiltration. Receives: Procedure: Continuous veno-venous haemodiafiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
time of nursing work required to realised a CVVHDF as a conventional and on line methods modality of supply compared to a method on-line
The end of the study for the patient corresponds to the end of CVVHDF conventional and on line.
Measured: Day 1
Secondary outcomes (1)
costs of CVVHDF performed using a conventional and on-line methods
The end of the study for the patient corresponds to the end of CVVHDF conventional and on line.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2009 (estimated)
- Study startSep 2010
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
Why it stopped: This study has never been started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Renal FailureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manolie Mehdi, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993733
- Sponsor's protocol ID
- 1008019
- Other IDs
- 2010-A00695-34
- Status last verified
- Mar 2016
- First submitted
- 9 Oct 2009
- Last updated
- 23 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Two Methods of Continuous Veno-venous Hemodiafiltration on Time Nursing Work in Intensive Care
- ClinicalTrials.gov ID
- NCT00993733
- Acronym / sponsor ID
- 1008019
- Conditions
- Acute Renal Failure
- Keywords
- hemodiafiltration, cost, dialysis solution, acute renal failure, intensive care unit
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study has never been started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 12 Oct 2009 (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.
The prevalence of acute renal failure in intensive care is estimated at between 5 and 20% depending on diagnostic criteria retained. And half of patients require the use of hemodialysis. Continuous veno-venous hemodiafiltration (CVVHDF) is one of the hemodialysis technique widely used in intensive care unit.
The CVVHDF is performed at the bedside, by a mobile generator with a semi permeable membrane, a blood circuit, a dialysate circuit and a feedback circuit.
The implementation of a CVVHDF requires the use of large amounts of biological liquid essential to enable the purification of blood during its passage through the artificial kidney.
The objective of this study is to assess time nursing work and the costs of each method.
Detailed description
The prevalence of acute renal failure in intensive care is estimated at between 5 and 20% depending on diagnostic criteria retained. And half of patients require the use of hemodialysis. Continuous veno-venous hemodiafiltration (CVVHDF) is one of the hemodialysis technique widely used in intensive care unit.
The CVVHDF is performed at the bedside, by a mobile generator with a semi permeable membrane, a blood circuit, a dialysate circuit and a feedback circuit.
The implementation of a CVVHDF requires the use of large amounts of biological liquid essential to enable the purification of blood during its passage through the artificial kidney. The biological fluid may be supplied to the generator of CVVHDF in 2 ways:
- The conventional method, the most used: the generator operates with pockets containing dialysis fluid, these pockets to be changed regularly by nurses
- The on-line method: the generator operates with a specific water system supplying the dialysis fluid available in every room of the unit The objective of this study is to assess time nursing work and the costs of each method.
For this, 15 patients will be included in this study. Each patient performs 12 hours of each method (conventional and online), whose order will be randomized.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CVVHDF on-line | Experimental | Procedure: Continuous veno-venous haemodiafiltrationCVVHDF using a central water treatment plant, providing dialysate directly to the patient. They will perform a continuous veno-venous haemodiafiltration. |
| classical CVVHDF | Experimental | Procedure: Continuous veno-venous haemodiafiltrationCVVHDF using a mobile generator with dialysate bags. They will perform a continuous veno-venous haemodiafiltration. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patient affiliated with or beneficiary of a social security category
- Patient with a renal failure requiring a CVVHDF for at least 2 cycles of 12 hours
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Continuous veno-venous haemodiafiltrationAlso: Classical CVVHDF : dialusate generator Prismaflex (HOSPAL), CVVHDF on-line : dialysate generator 5008 (Fresenius)Dialysis procedure administrated to the patients with acute renal failure | Procedure or surgery | CVVHDF on-line, classical CVVHDF |
Primary outcome
time of nursing work required to realised a CVVHDF as a conventional and on line methods modality of supply compared to a method on-line
Time frame: Day 1
The end of the study for the patient corresponds to the end of CVVHDF conventional and on line.
1 secondary outcome
costs of CVVHDF performed using a conventional and on-line methods
Time frame: Day 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2016.
- Individual participant dataSharing planned: No
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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.
Manolie Mehdi, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
Questions about this trial
What is this clinical trial studying?
A study testing Continuous veno-venous haemodiafiltration in people with Acute Renal Failure, run by Centre Hospitalier Universitaire de Saint Etienne.
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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 23 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
time of nursing work required to realised a CVVHDF as a conventional and on line methods modality of supply compared to a method on-line (time frame: 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 23 Mar 2016.