Catheter Related InfectionsPhase 2NCT01263574
Trial of 70% Ethanol Versus Heparin to Reduce the Rate of Central Line Infections in Children With Short Bowel Syndrome
A Phase 2 study testing 70% ethanol in people with Catheter Related Infections and Short Bowel Syndrome, run by Boston Children's Hospital at 1 site in United States.
Trial summary
This study is designed to determine if the use of 70% ethanol lock solution in central lines decreases the rate of central line infections in children with short bowel syndrome. While ethanol locks have been used safely in children, there has been no published research to date that clearly shows it is of definite… Read more about this study
- Who is it for?
- Ages 3 months and olderHealthy volunteers can take part
- Conditions the study is for
- Catheter Related Infections, Short Bowel Syndrome
- What is being tested?
- 70% ethanol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Sep 2012
- 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 3 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age >3 months
- Intestinal failure patients
- Silicone catheter for the administration of parenteral nutrition
Who cannot join
- Age < 3 months
- Weight < 5 kg
- Documented allergy to ethanol
- Evidence of tunnel site infection
- Patients receiving continuous renal replacement therapy
- Concomitant use of metronidazole
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: Trial of Ethanol Lock Therapy to Prevent Catheter Associated Blood Stream Infections
This study is designed to determine if the use of 70% ethanol lock solution in central lines decreases the rate of central line infections in children with short bowel syndrome. While ethanol locks have been used safely in children, there has been no published research to date that clearly shows it is of definite benefit in this group of patients.
- Conditions
- Catheter Related Infections, Short Bowel Syndrome
- Being tested
- 70% ethanol
- Keywords
- Catheter related infections prevention/control, Anti infective agents, Catheter related infections prevention
- Medical subject headings
- Catheter-Related Infections, Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
70% ethanolDrug
Also called ethanol lock
Administration of the lock solution will occur between cycles of parenteral nutrition. Lock solutions will be administered three days per week. The pre-measured volume of lock solution will then be injected into the catheter for 4 hours. Prior to the next instillation of medications into the catheter, the lock solution will be aspirated and discarded. Another 5mL flush of saline will then be instilled into the catheter prior to medication or parenteral nutrition administration. Volume of lock solution administered will be determined by catheter size.
| Study group | Role | What they receive |
|---|---|---|
| Heparinized Saline | Placebo comparator | This group will maintain their central lines patent with heparinized saline. Receives: Drug: 70% ethanol |
| Ethanol lock solution group | Experimental | Administration of the 70% ethanol lock solution will occur between cycles of parenteral nutrition. Randomized lock solutions will be administered three days per week. When patients have completed their parenteral nutrition, their central venous catheters will be flushed with 5mL saline, per current standards Receives: Drug: 70% ethanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheter associated blood stream infection (CABSI).
Published data in intensive care unit (ICU) patients with CABSI has noted that central venous catheter cultures had a specificity of 98% and a negative predictive value of 97%. In our study, we will define CABSI as a positive central venous catheter blood culture in the face of clinical signs of infection, when the catheter has been used in the last 48 hours prior to infection, and without other obvious source of infection. CABSI rate will be reported as number of infections per 1000 catheter days after 12 months of follow up.
Measured: Number of infections reported per 1000 catheter days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2010 (estimated)
- Study startFeb 2011 (estimated)
- Primary completionJun 2012 (estimated)
- Study completionSep 2012 (estimated)
Why it stopped: No participants. IND denied by FDA.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter Related InfectionsStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tom Jaksic, Boston Children's Hospital
- Investigators
- Tom Jaksic, M.D, Ph.D, Principal investigator, Boston Children's HospitalChristopher Duggan, M.D, MPH, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263574
- Sponsor's protocol ID
- 09-03-0132
- Status last verified
- Jun 2017
- First submitted
- 17 Dec 2010
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Ethanol Lock Therapy to Prevent Catheter Associated Blood Stream Infections
- ClinicalTrials.gov ID
- NCT01263574
- Acronym / sponsor ID
- 09-03-0132
- Conditions
- Catheter Related Infections, Short Bowel Syndrome
- Keywords
- Catheter related infections prevention/control, Anti infective agents, Catheter related infections prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants. IND denied by FDA.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Feb 2011 (estimated)
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 20 Dec 2010 (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.
This study is designed to determine if the use of 70% ethanol lock solution in central lines decreases the rate of central line infections in children with short bowel syndrome. While ethanol locks have been used safely in children, there has been no published research to date that clearly shows it is of definite benefit in this group of patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heparinized Saline | Placebo comparator | Drug: 70% ethanolThis group will maintain their central lines patent with heparinized saline. |
| Ethanol lock solution group | Experimental | Drug: 70% ethanolAdministration of the 70% ethanol lock solution will occur between cycles of parenteral nutrition. Randomized lock solutions will be administered three days per week. When patients have completed their parenteral nutrition, their central venous catheters will be flushed with 5mL saline, per current standards |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age >3 months
- Intestinal failure patients
- Silicone catheter for the administration of parenteral nutrition
Key exclusion criteria (6 listed)
- Age < 3 months
- Weight < 5 kg
- Documented allergy to ethanol
- Evidence of tunnel site infection
- Patients receiving continuous renal replacement therapy
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: ethanol lockAdministration of the lock solution will occur between cycles of parenteral nutrition. Lock solutions will be administered three days per week. The pre-measured volume of lock solution will then be injected into the catheter for 4 hours. Prior to the next instillation of medications into the catheter, the lock solution will be aspirated and discarded. Another 5mL flush of saline will then be instilled into the catheter prior to medication or parenteral nutrition administration. Volume of lock solution administered will be determined by catheter size. | Drug | Ethanol lock solution group, Heparinized Saline |
Primary outcome
Catheter associated blood stream infection (CABSI).
Time frame: Number of infections reported per 1000 catheter days.
Published data in intensive care unit (ICU) patients with CABSI has noted that central venous catheter cultures had a specificity of 98% and a negative predictive value of 97%. In our study, we will define CABSI as a positive central venous catheter blood culture in the face of clinical signs of infection, when the catheter has been used in the last 48 hours prior to infection, and without other obvious source of infection. CABSI rate will be reported as number of infections per 1000 catheter days after 12 months of follow up.
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 22 Jun 2017.
- 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.
Tom Jaksic, M.D, Ph.D principal investigator
Boston Children's Hospital
Christopher Duggan, M.D, MPH principal investigator
Boston Children's Hospital
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 70% ethanol in people with Catheter Related Infections and Short Bowel Syndrome, run by Boston Children's Hospital 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 3 inclusion and 6 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 22 Jun 2017. 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 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 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?
Catheter associated blood stream infection (CABSI). (time frame: Number of infections reported per 1000 catheter days.). 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 22 Jun 2017.