Acute Renal FailurePhase 3ELVISNCT00875069
Efficacy and Safety of Ethanol Lock Solution in Prevention of Catheter Related Bloodstream Infection for Patients Suffering Acute Renal Failure, and Hospitalized in Intensive Care Unit. A Multi-Center, Randomized, Versus Placebo, Double Blinded Clinical Trial
A Phase 3 study testing Ethanol in people with Acute Renal Failure and Infection, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The primary objective of the study is to demonstrate the efficacy of 60% ethanol lock solution in preventing major catheter related infections in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Failure, Infection
- What is being tested?
- Ethanol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,460 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2009to Feb 2013
- Phase
- Phase 3
- 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
- Patients of both genders, over 18 years,
- Patients admitted in ICU
- Dialysis catheter insertion for renal replacement therapy
- At least two renal replacement therapy sessions
- Written informed consent
- Social security
Who cannot join
- Pregnant or breastfeeding women
- Patient requiring dialysis on arteriovenous fistula or permanent catheter
- Known allergy to ethanol
- Dialysis catheter covered or impregnated with antimicrobial agent
- Dialysis catheter insertion before ICU admission
- Single-lumen dialysis catheters
- Patient whose death is likely to occur within hours after admission to ICU
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Ethanol Lock Solution in Prevention of Catheter Related Bloodstream Infection for Patients Suffering Acute Renal Failure, and Hospitalized in Intensive Care Unit. A Multi-Center, Randomized, Versus Placebo, Double Blinded Clinical Trial.
The primary objective of the study is to demonstrate the efficacy of 60% ethanol lock solution in preventing major catheter related infections in critically ill patients.
Read the detailed description
The primary objective of the study is to demonstrate the efficacy of 60% ethanol lock solution in preventing major catheter related infections in critically ill patients
- Conditions
- Acute Renal Failure, Infection
- Being tested
- Ethanol
- Keywords
- Nosocomial infection, Catheterization, Central Venous Ethanol, lock solution, intensive care units, Renal replacement therapy in ICU
- Medical subject headings
- Acute Kidney Injury, Infections, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EthanolOther
Dialysis catheter lock performed after renal replacement therapy session. Lock is instilling ethanol (or placebo) in each catheter lumen for 2 minutes before being withdrawn.
| Study group | Role | What they receive |
|---|---|---|
| ethanol | Experimental | Not described Receives: Other: Ethanol |
| placebo | Placebo comparator | Not described Receives: Other: Ethanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of major catheter-related infections (CRI) defined as either catheter-related clinical sepsis without bloodstream infection or catheter-related bloodstream infection (CRBSI), during the ICU stay
Measured: after renal replacement therapy session
Secondary outcomes (1)
frequencies of catheter colonization, severe mechanical complications, and adverse events
Measured: for two minutes before being withdrawn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2011
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Renal FailureStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,460 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertrand Souweine, Pr, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875069
- Sponsor's protocol ID
- CHU-0050
- Acronym
- ELVIS
- Status last verified
- Jun 2014
- First submitted
- 2 Apr 2009
- Last updated
- 20 May 2026
- Results posted
- No
Publications
Boyer A, Timsit JF, Klouche K, Canet E, Phan TN, Bohe J, Rubin S, Orieux A, Lautrette A, Gruson D, Souweine B. Aminoglycosides in Critically Ill Septic Patients With Acute Kidney Injury Receiving Continuous Renal Replacement Therapy: A Multicenter, Observational Study. Clin Ther. 2021 Jun;43(6):1116-1124. doi: 10.1016/j.clinthera.2021.04.011. Epub 2021 May 24.
PubMed 34039478Soum E, Timsit JF, Ruckly S, Gruson D, Canet E, Klouche K, Argaud L, Garrouste-Orgeas M, Mariat C, Vincent F, Cayot S, Darmon M, Bohe J, Schwebel C, Bouadma L, Dupuis C, Souweine B, Lautrette A. Predictive factors for severe long-term chronic kidney disease after acute kidney injury requiring renal replacement therapy in critically ill patients: an ancillary study of the ELVIS randomized controlled trial. Crit Care. 2022 Nov 29;26(1):367. doi: 10.1186/s13054-022-04233-4.
PubMed 36447221Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Megarbane B, Mira JP, Ruckly S, Souweine B, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable prediction model of central venous catheter-tip colonization in a cohort of five randomized trials. Crit Care. 2022 Jul 7;26(1):205. doi: 10.1186/s13054-022-04078-x.
PubMed 35799302Almeida BM, Moreno DH, Vasconcelos V, Cacione DG. Interventions for treating catheter-related bloodstream infections in people receiving maintenance haemodialysis. Cochrane Database Syst Rev. 2022 Apr 1;4(4):CD013554. doi: 10.1002/14651858.CD013554.pub2.
PubMed 35363884Souweine B, Lautrette A, Gruson D, Canet E, Klouche K, Argaud L, Bohe J, Garrouste-Orgeas M, Mariat C, Vincent F, Cayot S, Cointault O, Lepape A, Guelon D, Darmon M, Vesin A, Caillot N, Schwebel C, Boyer A, Azoulay E, Bouadma L, Timsit JF. Ethanol lock and risk of hemodialysis catheter infection in critically ill patients. A randomized controlled trial. Am J Respir Crit Care Med. 2015 May 1;191(9):1024-32. doi: 10.1164/rccm.201408-1431OC.
PubMed 25668557
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ethanol Lock Solution in Prevention of Catheter Related Bloodstream Infection for Patients Suffering Acute Renal Failure, and Hospitalized in Intensive Care Unit. A Multi-Center, Randomized, Versus Placebo, Double Blinded Clinical Trial.
- ClinicalTrials.gov ID
- NCT00875069
- Acronym / sponsor ID
- ELVIS / CHU-0050
- Conditions
- Acute Renal Failure, Infection
- Keywords
- Nosocomial infection, Catheterization, Central Venous Ethanol, lock solution, intensive care units, Renal replacement therapy in ICU
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,460 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 3 Apr 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 primary objective of the study is to demonstrate the efficacy of 60% ethanol lock solution in preventing major catheter related infections in critically ill patients.
Detailed description
The primary objective of the study is to demonstrate the efficacy of 60% ethanol lock solution in preventing major catheter related infections in critically ill patients
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ethanol | Experimental | Other: Ethanol |
| placebo | Placebo comparator | Other: Ethanol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients of both genders, over 18 years,
- Patients admitted in ICU
- Dialysis catheter insertion for renal replacement therapy
- At least two renal replacement therapy sessions
- Written informed consent
Key exclusion criteria (7 listed)
- Pregnant or breastfeeding women
- Patient requiring dialysis on arteriovenous fistula or permanent catheter
- Known allergy to ethanol
- Dialysis catheter covered or impregnated with antimicrobial agent
- Dialysis catheter insertion before ICU admission
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 |
|---|---|---|
| EthanolDialysis catheter lock performed after renal replacement therapy session. Lock is instilling ethanol (or placebo) in each catheter lumen for 2 minutes before being withdrawn. | Other | ethanol, placebo |
Primary outcome
The number of major catheter-related infections (CRI) defined as either catheter-related clinical sepsis without bloodstream infection or catheter-related bloodstream infection (CRBSI), during the ICU stay
Time frame: after renal replacement therapy session
1 secondary outcome
frequencies of catheter colonization, severe mechanical complications, and adverse events
Time frame: for two minutes before being withdrawn
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 20 May 2026.
- Results publication: PubMed 34039478Boyer A, Timsit JF, Klouche K, Canet E, Phan TN, Bohe J, Rubin S, Orieux A, Lautrette A, Gruson D, Souweine B. Aminoglycosides in Critically Ill Septic Patients With Acute Kidney Injury Receiving Continuous Renal Replacement Therapy: A Multicenter, Observational Study. Clin Ther. 2021 Jun;43(6):1116-1124. doi: 10.1016/j.clinthera.2021.04.011. Epub 2021 May 24.
- Derived from this study: PubMed 36447221Soum E, Timsit JF, Ruckly S, Gruson D, Canet E, Klouche K, Argaud L, Garrouste-Orgeas M, Mariat C, Vincent F, Cayot S, Darmon M, Bohe J, Schwebel C, Bouadma L, Dupuis C, Souweine B, Lautrette A. Predictive factors for severe long-term chronic kidney disease after acute kidney injury requiring renal replacement therapy in critically ill patients: an ancillary study of the ELVIS randomized controlled trial. Crit Care. 2022 Nov 29;26(1):367. doi: 10.1186/s13054-022-04233-4.
- Derived from this study: PubMed 35799302Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Megarbane B, Mira JP, Ruckly S, Souweine B, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable prediction model of central venous catheter-tip colonization in a cohort of five randomized trials. Crit Care. 2022 Jul 7;26(1):205. doi: 10.1186/s13054-022-04078-x.
- Derived from this study: PubMed 35363884Almeida BM, Moreno DH, Vasconcelos V, Cacione DG. Interventions for treating catheter-related bloodstream infections in people receiving maintenance haemodialysis. Cochrane Database Syst Rev. 2022 Apr 1;4(4):CD013554. doi: 10.1002/14651858.CD013554.pub2.
- Derived from this study: PubMed 25668557Souweine B, Lautrette A, Gruson D, Canet E, Klouche K, Argaud L, Bohe J, Garrouste-Orgeas M, Mariat C, Vincent F, Cayot S, Cointault O, Lepape A, Guelon D, Darmon M, Vesin A, Caillot N, Schwebel C, Boyer A, Azoulay E, Bouadma L, Timsit JF. Ethanol lock and risk of hemodialysis catheter infection in critically ill patients. A randomized controlled trial. Am J Respir Crit Care Med. 2015 May 1;191(9):1024-32. doi: 10.1164/rccm.201408-1431OC.
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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.
Bertrand Souweine, Pr 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?
A Phase 3 study testing Ethanol in people with Acute Renal Failure and Infection, 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 6 inclusion and 7 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 20 May 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The number of major catheter-related infections (CRI) defined as either catheter-related clinical sepsis without bloodstream infection or catheter-related bloodstream infection (CRBSI), during the ICU stay (time frame: after renal replacement therapy session). 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 NCT00875069, which also lists 5 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 20 May 2026.