Catheter Related InfectionNCT01229592
Ethanol in the Prevention of Central Venous Catheter Infections
A study testing Ethanol and Heparine in people with Catheter Related Infection, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
Trial summary
In recent years, several new methods for treatment of catheter-related bloodstream infections (CRBSI) such as antibiotic or antiseptic lock-therapy have been developed with variable success [1-10]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter Related Infection
- What is being tested?
- Ethanol and Heparine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2009to Feb 2012
- 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
- older than 18 years old
- Signed informed consent
- central Venous catheter more than 48 hours placed
Who cannot join
- pregnancy
- denial Informed consent Form
- ethanol intolerance
- Liver cirrhosis
Trial locations and contacts
1 site in 1 country.
Spain1 site
Servicio de Microbiología y Enfermedades Infecciosas. Hospital GU Gregorio Marañon
Madrid, Madrid, 28007
About this study
Official title: Clinical Study of Ethanol Lock-therapy in the Prevention of Non-tunnelled, Short Term Central Venous Catheter Associated Infections
In recent years, several new methods for treatment of catheter-related bloodstream infections (CRBSI) such as antibiotic or antiseptic lock-therapy have been developed with variable success [1-10].
Long-term tunnelled central venous catheters provide a reliable access for administration of chemotherapy, parenteral nutrition or haemodialysis. However, they are not free of complications such as bacteremia. The need to preserve these intra-vascular devices as long as is possible in patients in whom conventional treatment was failed makes emerge antibiotic lock-technique.
Read more
Ethanol lock-therapy was demonstrate her utility in this cases. But no study has yet been published using the ethanol lock-therapy as a prophylactic therapy in catheter related infections, neither her application in short-term CVCs.
Objectives: To investigate the value of a ethanol-lock solution in the prophylaxis of non-tunnelled short-term CVC related infections in a heart post-surgical intensive care unit (HPSICU).
Methods: An academic, prospective, randomized and controlled clinical trial is proposed. Patients at HPSICU who have a CVC more than 48 h will be randomized in two arms (ethanol-lock or control group with conventional measurements such as anticoagulants). In the follow-up period, we will register all necessary data to evaluate the end-points of study (CBRSI rate, catheter colonization rate, hospital stay, antimicrobial consume and adverse events due to ethanol).
- Conditions
- Catheter Related Infection
- Being tested
- Ethanol, Heparine
- Keywords
- infection, catheter, bacteriaemia, ethanol
- Medical subject headings
- Catheter-Related Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EthanolDrug
Every three day lock using Ethanol(70%)in all the lumen(1ml/per lumen) of the Catheter
HeparineDrug
Every three day lock using Heparin(Fibrilin TM) 3ml in all the lumen of the Catheter
| Study group | Role | What they receive |
|---|---|---|
| Ethanol | Experimental | Every three day lock using Ethanol in all the lumen of the Catheter Receives: Drug: Ethanol |
| Heparine | Active comparator | Every three day lock using Heparine in all the lumen of the Catheter Receives: Drug: Heparine |
What is being measured
The primary outcome is the main question the study is designed to answer.
catheter infectionrelated incidence rates
decrease on catheter infection related incidence rates in comparison to the institution incidence figures
Measured: 2 years
Secondary outcomes (2)
cathether bacteriaemia related rate
versus Institution rate figures
Measured: 2 years
antimicrobial consume
Defined Diary Dosis(DDDs)in both arms
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2010 (estimated)
- Study startDec 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Why it stopped: The non significative reduction of CRBSI adverse events,the need for a high frecuency of catheter manipulations
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 Catheter Related 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01229592
- Sponsor's protocol ID
- EC07/90653
- Other IDs
- 2007-007063-24
- Status last verified
- Jul 2012
- First submitted
- 18 Oct 2010
- Last updated
- 17 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Perez-Granda MJ, Barrio JM, Munoz P, Hortal J, Rincon C, Rabadan PM, Pernia MS, Bouza E. Ethanol lock therapy (E-Lock) in the prevention of catheter-related bloodstream infections (CR-BSI) after major heart surgery (MHS): a randomized clinical trial. PLoS One. 2014 Mar 27;9(3):e91838. doi: 10.1371/journal.pone.0091838. eCollection 2014.
PubMed 24675993
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Ethanol Lock-therapy in the Prevention of Non-tunnelled, Short Term Central Venous Catheter Associated Infections
- ClinicalTrials.gov ID
- NCT01229592
- Acronym / sponsor ID
- EC07/90653
- Conditions
- Catheter Related Infection
- Keywords
- infection, catheter, bacteriaemia, ethanol
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The non significative reduction of CRBSI adverse events,the need for a high frecuency of catheter manipulations
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 28 Oct 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.
In recent years, several new methods for treatment of catheter-related bloodstream infections (CRBSI) such as antibiotic or antiseptic lock-therapy have been developed with variable success [1-10].
Long-term tunnelled central venous catheters provide a reliable access for administration of chemotherapy, parenteral nutrition or haemodialysis. However, they are not free of complications such as bacteremia. The need to preserve these intra-vascular devices as long as is possible in patients in whom conventional treatment was failed makes emerge antibiotic lock-technique.
Ethanol lock-therapy was demonstrate her utility in this cases. But no study has yet been published using the ethanol lock-therapy as a prophylactic therapy in catheter related infections, neither her application in short-term CVCs.
Objectives: To investigate the value of a ethanol-lock solution in the prophylaxis of non-tunnelled short-term CVC related infections in a heart post-surgical intensive care unit (HPSICU).
Methods: An academic, prospective, randomized and controlled clinical trial is proposed. Patients at HPSICU who have a CVC more than 48 h will be randomized in two arms (ethanol-lock or control group with conventional measurements such as anticoagulants). In the follow-up period, we will register all necessary data to evaluate the end-points of study (CBRSI rate, catheter colonization rate, hospital stay, antimicrobial consume and adverse events due to ethanol).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ethanol | Experimental | Drug: EthanolEvery three day lock using Ethanol in all the lumen of the Catheter |
| Heparine | Active comparator | Drug: HeparineEvery three day lock using Heparine in all the lumen of the Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- older than 18 years old
- Signed informed consent
- central Venous catheter more than 48 hours placed
Key exclusion criteria (4 listed)
- pregnancy
- denial Informed consent Form
- ethanol intolerance
- Liver cirrhosis
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 |
|---|---|---|
| EthanolEvery three day lock using Ethanol(70%)in all the lumen(1ml/per lumen) of the Catheter | Drug | Ethanol |
| HeparineEvery three day lock using Heparin(Fibrilin TM) 3ml in all the lumen of the Catheter | Drug | Heparine |
Primary outcome
catheter infectionrelated incidence rates
Time frame: 2 years
decrease on catheter infection related incidence rates in comparison to the institution incidence figures
2 secondary outcomes
cathether bacteriaemia related rate
Time frame: 2 years
antimicrobial consume
Time frame: 2 years
Results and safety
The study was stopped early (reason given: The non significative reduction of CRBSI adverse events,the need for a high frecuency of catheter manipulations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2012.
- Derived from this study: PubMed 24675993Perez-Granda MJ, Barrio JM, Munoz P, Hortal J, Rincon C, Rabadan PM, Pernia MS, Bouza E. Ethanol lock therapy (E-Lock) in the prevention of catheter-related bloodstream infections (CR-BSI) after major heart surgery (MHS): a randomized clinical trial. PLoS One. 2014 Mar 27;9(3):e91838. doi: 10.1371/journal.pone.0091838. eCollection 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ethanol and Heparine in people with Catheter Related Infection, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
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 4 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 17 Jul 2012. 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 Spain. 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 was stopped early (reason given: The non significative reduction of CRBSI adverse events,the need for a high frecuency of catheter manipulations). 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?
catheter infectionrelated incidence rates (time frame: 2 years). 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 NCT01229592, 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 17 Jul 2012.