Bloodstream InfectionPhase 3NCT00680459
Ethanol Locks for the Treatment of Central Venous Line Infections
A Phase 3 study testing 70% ethanol and heparin flush solution in people with Bloodstream Infection, run by Baystate Medical Center at 1 site in United States.
Trial summary
Ethanol Locks as an Adjunct Treatment for Central Venous Line Infections Purpose To evaluate the effectiveness of a 70% ethanol lock solution when used as an adjunct therapy with antibiotics to treat central venous line infections Study Design Randomized Controlled Trial Study Protocol Only those patients meeting all… Read more about this study
- Who is it for?
- Ages 6 months to 23 years
- Conditions the study is for
- Bloodstream Infection
- What is being tested?
- 70% ethanol and heparin flush solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jun 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 months to 23 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age 6 months-23 years
- documented central line infection with bacteria or fungus (positive blood culture)
Who cannot join
- allergy or intolerance to ethanol
- pregnant or breastfeeding
- central line tunnel or exit site infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Baystate Medical Center
Springfield, Massachusetts, 01199
About this study
Ethanol Locks as an Adjunct Treatment for Central Venous Line Infections
Purpose To evaluate the effectiveness of a 70% ethanol lock solution when used as an adjunct therapy with antibiotics to treat central venous line infections
Read more
Study Design Randomized Controlled Trial
Study Protocol Only those patients meeting all inclusion criteria and no exclusion criteria will be eligible to participate in this study. Once identified, signed informed consent will be obtained from the patient's guardian and the patient himself/herself depending on age. Patients will be randomized into 2 groups: Group 1 - those patients who will receive ethanol lock therapy and Group 2- those patients who will receive placebo therapy in the form of a heparin lock solution.
Outcome Measures Treatment success as defined by-
- Clearance of the infection as documented by negative blood cultures on day 6 (one day after completed of lock treatment)
- Preservation of the line at 30 days post treatment (day 35 of the study), this will be documented by a chart review in CIS and telephone interview to ensure no further growth from blood cultures or infections
Treatment failure as defined by-
- Clinical worsening during treatment
- Removal of the line due to persistent infection or sepsis
- Recurrence of infection with the same pathogen within 30 days
Read the detailed description
Ethanol Lock Technique Protocol (adapted from the Children's Hospital Los Angeles)
- Obtain a 3ml syringe made by the Baystate Pharmacy which will contain either sterile 70% ethanol solution or 10 units/ml heparin flush solution. Randomization into study groups will be performed by the pharmacy in patient blocks of 10. Treating physician and nurses will be blinded to patient group assignment. Syringes will be labeled "70% ethanol/heparin lock Study Solution"
- Cleanse Hands
- Use aseptic Technique throughout procedure
- Clean injection cap/posi-flow cap with alcohol for 30 seconds and let dry
- Unclamp the catheter and gently flush with normal saline to ensure patency of the catheter
- Instill ethanol/heparin lock into the catheter to fill volume
- Broviac Single Lumen 4.2 Fr (ID 0.7) Dose 0.8ml
- Broviac Single Lumen 6.6 Fr (ID 1mm) Dose 0.8ml
- Med-comp Single Lumen Catheter Dose 1.2ml
- Hickman Double Lumen 7 Fr Distal (ID 1mm) Dose 1.2ml
- Hickman Double Lumen 9 Fr Proximal (ID 0.7) Dose 1.2ml
- Med-comp Double Lumen 8 or 10 Fr Dose 1.2ml
- Port-a-cath- Any Port (including priming tubing) Dose 1.9ml
- Clamp the catheter
- Label the locked lumen with the provided label so that med is not flushed through the catheter
- Let ethanol dwell in catheter continuously for 4 hours
- When ethanol has dwelled for 4 hours, withdraw and discard the lock solution
- The above procedure should be repeated daily for 5 consecutive days
- The above procedure should be repeated to each lumen of the central venous catheter daily if there are multiple lumens
- Conditions
- Bloodstream Infection
- Being tested
- 70% ethanol, heparin flush solution
- Keywords
- central line infection, 70% ethanol, Sepsis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
70% ethanolDrug
Also called alcohol
70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. Volume of solution instilled varies from 0.8-1.9ml depending on volume of the lumen and hub of the particular size line being treated. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
heparin flush solutionDrug
Also called anticoagulant
heparin flush (10 units/ml) lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. Volume of solution instilled varies from 0.8-1.9ml depending on volume of the lumen and hub of the particular size line being treated. Heparin lock solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days. Receives: Drug: 70% ethanol |
| 2 | Placebo comparator | heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days. Receives: Drug: heparin flush solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance of Central Venous Line Infection by Day 6 of Study
Measured: 6 days
Secondary outcomes (2)
Preservation of Central Venous Line (Line Not Requiring Removal) by Day 35 of Study
Measured: 35 days
Recurrence of Central Venous Line Infection Within 35 Days of Enrollment
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2008 (estimated)
- Study startMay 2008
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: inability to enroll adequate number of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bloodstream InfectionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baystate Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, christine mckiernan, Baystate Medical Center
- Investigators
- Christine A McKiernan, MD, Principal investigator, Baystate Medical CenterAmanda Conti, MD, Study director, Baystate Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680459
- Sponsor's protocol ID
- IRB08-064
- Status last verified
- Jan 2014
- First submitted
- 16 May 2008
- Last updated
- 12 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Onland W, Shin CE, Fustar S, Rushing T, Wong WY. Ethanol-lock technique for persistent bacteremia of long-term intravascular devices in pediatric patients. Arch Pediatr Adolesc Med. 2006 Oct;160(10):1049-53. doi: 10.1001/archpedi.160.10.1049.
PubMed 17018464
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethanol Locks for the Treatment of Central Venous Line Infections
- ClinicalTrials.gov ID
- NCT00680459
- Acronym / sponsor ID
- IRB08-064
- Conditions
- Bloodstream Infection
- Keywords
- central line infection, 70% ethanol, Sepsis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inability to enroll adequate number of patients
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Baystate Medical CenterUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 20 May 2008 (estimated)
- Results
- Posted 12 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ethanol Locks as an Adjunct Treatment for Central Venous Line Infections
Purpose To evaluate the effectiveness of a 70% ethanol lock solution when used as an adjunct therapy with antibiotics to treat central venous line infections
Study Design Randomized Controlled Trial
Study Protocol Only those patients meeting all inclusion criteria and no exclusion criteria will be eligible to participate in this study. Once identified, signed informed consent will be obtained from the patient's guardian and the patient himself/herself depending on age. Patients will be randomized into 2 groups: Group 1 - those patients who will receive ethanol lock therapy and Group 2- those patients who will receive placebo therapy in the form of a heparin lock solution.
Outcome Measures Treatment success as defined by-
- Clearance of the infection as documented by negative blood cultures on day 6 (one day after completed of lock treatment)
- Preservation of the line at 30 days post treatment (day 35 of the study), this will be documented by a chart review in CIS and telephone interview to ensure no further growth from blood cultures or infections
Treatment failure as defined by-
- Clinical worsening during treatment
- Removal of the line due to persistent infection or sepsis
- Recurrence of infection with the same pathogen within 30 days
Detailed description
Ethanol Lock Technique Protocol (adapted from the Children's Hospital Los Angeles)
- Obtain a 3ml syringe made by the Baystate Pharmacy which will contain either sterile 70% ethanol solution or 10 units/ml heparin flush solution. Randomization into study groups will be performed by the pharmacy in patient blocks of 10. Treating physician and nurses will be blinded to patient group assignment. Syringes will be labeled "70% ethanol/heparin lock Study Solution"
- Cleanse Hands
- Use aseptic Technique throughout procedure
- Clean injection cap/posi-flow cap with alcohol for 30 seconds and let dry
- Unclamp the catheter and gently flush with normal saline to ensure patency of the catheter
- Instill ethanol/heparin lock into the catheter to fill volume
- Broviac Single Lumen 4.2 Fr (ID 0.7) Dose 0.8ml
- Broviac Single Lumen 6.6 Fr (ID 1mm) Dose 0.8ml
- Med-comp Single Lumen Catheter Dose 1.2ml
- Hickman Double Lumen 7 Fr Distal (ID 1mm) Dose 1.2ml
- Hickman Double Lumen 9 Fr Proximal (ID 0.7) Dose 1.2ml
- Med-comp Double Lumen 8 or 10 Fr Dose 1.2ml
- Port-a-cath- Any Port (including priming tubing) Dose 1.9ml
- Clamp the catheter
- Label the locked lumen with the provided label so that med is not flushed through the catheter
- Let ethanol dwell in catheter continuously for 4 hours
- When ethanol has dwelled for 4 hours, withdraw and discard the lock solution
- The above procedure should be repeated daily for 5 consecutive days
- The above procedure should be repeated to each lumen of the central venous catheter daily if there are multiple lumens
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 70% ethanol70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days. |
| 2 | Placebo comparator | Drug: heparin flush solutionheparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days. |
Who may qualify
- Ages
- 6 months to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- age 6 months-23 years
- documented central line infection with bacteria or fungus (positive blood culture)
Key exclusion criteria (3 listed)
- allergy or intolerance to ethanol
- pregnant or breastfeeding
- central line tunnel or exit site infection
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 |
|---|---|---|
| 70% ethanolAlso: alcohol70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. Volume of solution instilled varies from 0.8-1.9ml depending on volume of the lumen and hub of the particular size line being treated. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days. | Drug | 1 |
| heparin flush solutionAlso: anticoagulantheparin flush (10 units/ml) lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. Volume of solution instilled varies from 0.8-1.9ml depending on volume of the lumen and hub of the particular size line being treated. Heparin lock solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days. | Drug | 2 |
Primary outcome
Clearance of Central Venous Line Infection by Day 6 of Study
Time frame: 6 days
2 secondary outcomes
Preservation of Central Venous Line (Line Not Requiring Removal) by Day 35 of Study
Time frame: 35 days
Recurrence of Central Venous Line Infection Within 35 Days of Enrollment
Time frame: 35 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17018464Onland W, Shin CE, Fustar S, Rushing T, Wong WY. Ethanol-lock technique for persistent bacteremia of long-term intravascular devices in pediatric patients. Arch Pediatr Adolesc Med. 2006 Oct;160(10):1049-53. doi: 10.1001/archpedi.160.10.1049.
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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.
Christine A McKiernan, MD principal investigator
Baystate Medical Center
Amanda Conti, MD study director
Baystate Medical Center
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 70% ethanol and heparin flush solution in people with Bloodstream Infection, run by Baystate Medical Center at 1 site in United States.
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 3 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 12 Mar 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 United States. 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?
Yes. Results are posted in the registry (first posted 12 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clearance of Central Venous Line Infection by Day 6 of Study (time frame: 6 days). 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 NCT00680459, 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 12 Mar 2014.