Renal Failure, AcuteNCT01403220
The Efficacity of Hemodiafiltration Versus Hemofiltration for Renal Insufficiency During Intensive Care
A study testing Hemodiafiltration first and Hemofiltration first in people with Renal Failure, Acute, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The primary objective of this study is to compare the efficacity of hemodiafiltration and hemofiltration for decreasing plasma urea at 12h among intensive care patients. Secondary objectives include comparing urea clearance, filter duration, and %down-time, between the two techniques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure, Acute
- What is being tested?
- Hemodiafiltration first and Hemofiltration first
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2012to 17 Mar 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- According to RIFLE score, patient is stage 'F'
- The patient must be insured or beneficiary of a health insurance plan
- The patient meets at least one of the following criteria:
- metabolic acidosis (pH < 7.2), excluding keto-acidosis
- plasma urea > 25 mmol/l
- hyper-hydration is not controlled by diuretics
Who cannot join
- Chronic, terminal renal insufficiency with dialysis
- The patient is under judicial protection, under tutorship or curatorship
- Suspect hyperkaliemia (Kaliemia > 6.5 mmol/l with electrocardiographic effects)
- Intoxications treated via dialysis
- Pregnant, lactating, parturient women
- Medical indication for localized citrate anticoagulation
- dialysis of less than 12 h
- patient or representative refuses to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacity of Hemodiafiltration Versus Hemofiltration for Renal Insufficiency During Intensive Care: a Randomized, Open, Cross-over Study
The primary objective of this study is to compare the efficacity of hemodiafiltration and hemofiltration for decreasing plasma urea at 12h among intensive care patients. Secondary objectives include comparing urea clearance, filter duration, and %down-time, between the two techniques.
- Conditions
- Renal Failure, Acute
- Being tested
- Hemodiafiltration first, Hemofiltration first
- 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.
Hemodiafiltration firstProcedure or surgery
Patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemodiafiltration.
Hemofiltration firstProcedure or surgery
Patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemofiltration.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (hemodiafiltration first) | Active comparator | This group of patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemodiafiltration. Receives: Procedure: Hemodiafiltration first |
| Group 2 (hemofiltration first) | Active comparator | This group of patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemofiltration. Receives: Procedure: Hemofiltration first |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of dialysis sequences for which the rate of plasma urea reduction > 60%.
Proportion of dialysis sequences for which the rate of plasma urea reduction > 60%. Rate of plasma urea reduction = (initial urea concentration - urea concentration after 12h our dialysis)/initial urea concentration.
Measured: 12 hours
Secondary outcomes (6)
Proportion of dialysis sequences for which the rate of plasma urea reduction > 60%.
Proportion of dialysis sequences for which the rate of plasma urea reduction > 60%. Rate of plasma urea reduction = (initial urea concentration - urea concentration after 12h our dialysis)/initial urea concentration.
Measured: 24 hours
Urea clearance (ml/min) for the dialysis sequence under study
Urea clearance (ml/min) for the dialysis sequence under study.
Measured: 12 hours
Filter lifespan (hours) for the dialysis sequence under study.
Filter lifespan (hours) for the dialysis sequence under study.
Measured: 12 hours.
The percentage down-time for the first 24 hours of dialysis
The percentage down-time for the first 24 hours of dialysis = (number of hours where the exchange is not effective / 24 hours)*100
Measured: 24 hours
Fluid replacement (yes/no)
Was fluid replacement necessary during the studied dialysis sequence?
Measured: 12 hours
Fluid replacement (yes/no)
Was fluid replacement necessary during the studied dialysis sequence?
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startApr 2012
- Primary completion17 Mar 2015
- Study completion17 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Renal Failure, AcuteStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal Jeannes, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403220
- Sponsor's protocol ID
- LOCAL/2011/PJ-02
- Other IDs
- 2011-A01550-41
- Status last verified
- Mar 2015
- First submitted
- 25 Jul 2011
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Roger C, Muller L, Wallis SC, Louart B, Saissi G, Lipman J, Lefrant JY, Roberts JA. Population pharmacokinetics of linezolid in critically ill patients on renal replacement therapy: comparison of equal doses in continuous venovenous haemofiltration and continuous venovenous haemodiafiltration. J Antimicrob Chemother. 2016 Feb;71(2):464-70. doi: 10.1093/jac/dkv349. Epub 2015 Nov 3.
PubMed 26538503Roger C, Wallis SC, Muller L, Saissi G, Lipman J, Bruggemann RJ, Lefrant JY, Roberts JA. Caspofungin Population Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-Venous Haemofiltration or Haemodiafiltration. Clin Pharmacokinet. 2017 Sep;56(9):1057-1068. doi: 10.1007/s40262-016-0495-z.
PubMed 28035589Roger C, Wallis SC, Muller L, Saissi G, Lipman J, Lefrant JY, Roberts JA. Influence of Renal Replacement Modalities on Amikacin Population Pharmacokinetics in Critically Ill Patients on Continuous Renal Replacement Therapy. Antimicrob Agents Chemother. 2016 Jul 22;60(8):4901-9. doi: 10.1128/AAC.00828-16. Print 2016 Aug.
PubMed 27270279
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacity of Hemodiafiltration Versus Hemofiltration for Renal Insufficiency During Intensive Care: a Randomized, Open, Cross-over Study
- ClinicalTrials.gov ID
- NCT01403220
- Acronym / sponsor ID
- LOCAL/2011/PJ-02
- Conditions
- Renal Failure, Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- 17 Mar 2015 (actual)
- Study completion
- 17 Mar 2015 (actual)
- First posted
- 27 Jul 2011 (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 primary objective of this study is to compare the efficacity of hemodiafiltration and hemofiltration for decreasing plasma urea at 12h among intensive care patients. Secondary objectives include comparing urea clearance, filter duration, and %down-time, between the two techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (hemodiafiltration first) | Active comparator | Procedure: Hemodiafiltration firstThis group of patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemodiafiltration. |
| Group 2 (hemofiltration first) | Active comparator | Procedure: Hemofiltration firstThis group of patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemofiltration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- According to RIFLE score, patient is stage 'F'
- The patient must be insured or beneficiary of a health insurance plan
- The patient meets at least one of the following criteria:
- metabolic acidosis (pH < 7.2), excluding keto-acidosis
- plasma urea > 25 mmol/l
Key exclusion criteria (8 listed)
- Chronic, terminal renal insufficiency with dialysis
- The patient is under judicial protection, under tutorship or curatorship
- Suspect hyperkaliemia (Kaliemia > 6.5 mmol/l with electrocardiographic effects)
- Intoxications treated via dialysis
- Pregnant, lactating, parturient women
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 |
|---|---|---|
| Hemodiafiltration firstPatients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemodiafiltration. | Procedure or surgery | Group 1 (hemodiafiltration first) |
| Hemofiltration firstPatients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemofiltration. | Procedure or surgery | Group 2 (hemofiltration first) |
Primary outcome
Proportion of dialysis sequences for which the rate of plasma urea reduction > 60%.
Time frame: 12 hours
Proportion of dialysis sequences for which the rate of plasma urea reduction > 60%. Rate of plasma urea reduction = (initial urea concentration - urea concentration after 12h our dialysis)/initial urea concentration.
6 secondary outcomes
Proportion of dialysis sequences for which the rate of plasma urea reduction > 60%.
Time frame: 24 hours
Urea clearance (ml/min) for the dialysis sequence under study
Time frame: 12 hours
Filter lifespan (hours) for the dialysis sequence under study.
Time frame: 12 hours.
The percentage down-time for the first 24 hours of dialysis
Time frame: 24 hours
Fluid replacement (yes/no)
Time frame: 12 hours
Fluid replacement (yes/no)
Time frame: 24 hours
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 17 Nov 2025.
- Results publication: PubMed 26538503Roger C, Muller L, Wallis SC, Louart B, Saissi G, Lipman J, Lefrant JY, Roberts JA. Population pharmacokinetics of linezolid in critically ill patients on renal replacement therapy: comparison of equal doses in continuous venovenous haemofiltration and continuous venovenous haemodiafiltration. J Antimicrob Chemother. 2016 Feb;71(2):464-70. doi: 10.1093/jac/dkv349. Epub 2015 Nov 3.
- Derived from this study: PubMed 28035589Roger C, Wallis SC, Muller L, Saissi G, Lipman J, Bruggemann RJ, Lefrant JY, Roberts JA. Caspofungin Population Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-Venous Haemofiltration or Haemodiafiltration. Clin Pharmacokinet. 2017 Sep;56(9):1057-1068. doi: 10.1007/s40262-016-0495-z.
- Derived from this study: PubMed 27270279Roger C, Wallis SC, Muller L, Saissi G, Lipman J, Lefrant JY, Roberts JA. Influence of Renal Replacement Modalities on Amikacin Population Pharmacokinetics in Critically Ill Patients on Continuous Renal Replacement Therapy. Antimicrob Agents Chemother. 2016 Jul 22;60(8):4901-9. doi: 10.1128/AAC.00828-16. Print 2016 Aug.
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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.
Pascal Jeannes, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemodiafiltration first and Hemofiltration first in people with Renal Failure, Acute, run by Centre Hospitalier Universitaire de Nīmes 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 6 inclusion and 8 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 17 Nov 2025. 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?
Proportion of dialysis sequences for which the rate of plasma urea reduction > 60%. (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01403220, which also lists 3 linked publications.
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 17 Nov 2025.