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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-007063-24 | EudraCT Number |
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The non significative reduction of CRBSI adverse events,the need for a high frecuency of catheter manipulations
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ethanol | Experimental | Every three day lock using Ethanol in all the lumen of the Catheter |
|
| Heparine | Active Comparator | Every three day lock using Heparine in all the lumen of the Catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ethanol | Drug | Every three day lock using Ethanol(70%)in all the lumen(1ml/per lumen) of the Catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| catheter infectionrelated incidence rates | decrease on catheter infection related incidence rates in comparison to the institution incidence figures | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| cathether bacteriaemia related rate | versus Institution rate figures | 2 years |
| antimicrobial consume | Defined Diary Dosis(DDDs)in both arms |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Servicio de MicrobiologÃa y Enfermedades Infecciosas. Hospital GU Gregorio Marañon | Madrid | Madrid | 28007 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24675993 | Derived | 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. |
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| ID | Term |
|---|---|
| D055499 | Catheter-Related Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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| Heparine | Drug | Every three day lock using Heparin(Fibrilin TM) 3ml in all the lumen of the Catheter |
|
| 2 years |
| D002241 |
| Carbohydrates |