End Stage Renal Failure, HemodialysisPhase 2EthanolNCT00563342
Catheters Dysfunction Rate After Instillation of Ethanol 60% Lock Solution in Tunneled Silicone Catheter of Chronic Hemodialysis Patients
A Phase 2 study testing Ethanol in people with End Stage Renal Failure, Hemodialysis, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The primary objective of the study is to examine the risk of catheter dysfunction during the dialysis session that follows the instillation of ethanol 60% as lock solution in tunneled silicone catheters of end stage renal failure patients treated by hemodialysis. The catheters dysfunction rate is the primary outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Failure, Hemodialysis
- What is being tested?
- Ethanol
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2007to Mar 2008
- Phase
- Phase 2
- 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,
- Chronic hemodialysis 3 times a week, with two tunnel silicone catheters since at least 15 days,
- Written informed consent
- Social security
Who cannot join
- Antibiotic therapy during selection phase,
- Partial or complete catheter occlusion during selection phase,
- Venous pressure at dialysis connection > 300 mmHg,
- Known allergy to ethanol,
- Patient involved in any other clinical trial or in the exclusion period
- Severe co-morbidity
Show all 10Show fewer
- Acute or chronic infectious disease
- Evolutive neoplasia,
- HIV, HCV positive serology at inclusion,
- Scheduled surgery
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of the study is to examine the risk of catheter dysfunction during the dialysis session that follows the instillation of ethanol 60% as lock solution in tunneled silicone catheters of end stage renal failure patients treated by hemodialysis.
The catheters dysfunction rate is the primary outcome. The dysfunction is defined as partial or complete occlusion or infection associated with dialysis catheter.
As a secondary outcome, the dialysis quality is also examined (urea reduction rate, total ultrafiltration)
- Conditions
- End Stage Renal Failure, Hemodialysis
- Being tested
- Ethanol
- Keywords
- Ethanol, lock solution, infection
- Medical subject headings
- Renal Insufficiency, Chronic, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EthanolDrug
Examine the risk of catheter dysfunction during the dialysis session that follows the instillation of ethanol 60% as lock solution in tunneled silicone catheters of end stage renal failure patients treated by hemodialysis
What is being measured
The primary outcome is the main question the study is designed to answer.
The catheters dysfunction rate
Measured: as partial or complete occlusion or infection associated with dialysis catheter
Secondary outcomes (1)
The dialysis quality is also examined (urea reduction rate, total ultrafiltration)
Measured: as partial or complete occlusion or infection associated with dialysis catheter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startJun 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Failure, HemodialysisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Investigators
- Bertrand Souweine, Pr, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563342
- Sponsor's protocol ID
- CHU-0027
- Acronym
- Ethanol
- Status last verified
- Oct 2008
- First submitted
- 22 Nov 2007
- Last updated
- 8 Oct 2008
- Results posted
- No
Publications
Coupez E, Timsit JF, Ruckly S, Schwebel C, Gruson D, Canet E, Klouche K, Argaud L, Bohe J, Garrouste-Orgeas M, Mariat C, Vincent F, Cayot S, Cointault O, Lepape A, Darmon M, Boyer A, Azoulay E, Bouadma L, Lautrette A, Souweine B. Guidewire exchange vs new site placement for temporary dialysis catheter insertion in ICU patients: is there a greater risk of colonization or dysfunction? Crit Care. 2016 Jul 30;20(1):230. doi: 10.1186/s13054-016-1402-6.
PubMed 27473868
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheters Dysfunction Rate After Instillation of Ethanol 60% Lock Solution in Tunneled Silicone Catheter of Chronic Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT00563342
- Acronym / sponsor ID
- Ethanol / CHU-0027
- Conditions
- End Stage Renal Failure, Hemodialysis
- Keywords
- Ethanol, lock solution, infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 26 Nov 2007 (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 examine the risk of catheter dysfunction during the dialysis session that follows the instillation of ethanol 60% as lock solution in tunneled silicone catheters of end stage renal failure patients treated by hemodialysis.
The catheters dysfunction rate is the primary outcome. The dysfunction is defined as partial or complete occlusion or infection associated with dialysis catheter.
As a secondary outcome, the dialysis quality is also examined (urea reduction rate, total ultrafiltration)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of both genders, over 18 years,
- Chronic hemodialysis 3 times a week, with two tunnel silicone catheters since at least 15 days,
- Written informed consent
- Social security
Key exclusion criteria (10 listed)
- Antibiotic therapy during selection phase,
- Partial or complete catheter occlusion during selection phase,
- Venous pressure at dialysis connection > 300 mmHg,
- Known allergy to ethanol,
- Patient involved in any other clinical trial or in the exclusion period
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 |
|---|---|---|
| EthanolExamine the risk of catheter dysfunction during the dialysis session that follows the instillation of ethanol 60% as lock solution in tunneled silicone catheters of end stage renal failure patients treated by hemodialysis | Drug | – |
Primary outcome
The catheters dysfunction rate
Time frame: as partial or complete occlusion or infection associated with dialysis catheter
1 secondary outcome
The dialysis quality is also examined (urea reduction rate, total ultrafiltration)
Time frame: as partial or complete occlusion or infection associated with dialysis catheter
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2008.
- Derived from this study: PubMed 27473868Coupez E, Timsit JF, Ruckly S, Schwebel C, Gruson D, Canet E, Klouche K, Argaud L, Bohe J, Garrouste-Orgeas M, Mariat C, Vincent F, Cayot S, Cointault O, Lepape A, Darmon M, Boyer A, Azoulay E, Bouadma L, Lautrette A, Souweine B. Guidewire exchange vs new site placement for temporary dialysis catheter insertion in ICU patients: is there a greater risk of colonization or dysfunction? Crit Care. 2016 Jul 30;20(1):230. doi: 10.1186/s13054-016-1402-6.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ethanol in people with End Stage Renal Failure, Hemodialysis, 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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 8 Oct 2008. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early. Results are not available in the source record.
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 catheters dysfunction rate (time frame: as partial or complete occlusion or infection associated with dialysis catheter). 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 NCT00563342, which also lists 1 linked publication.
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 8 Oct 2008.