Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-26 @ 7:37 PM
Study NCT ID:
NCT01229592
Status:
TERMINATED
Last Update Posted:
2012-07-17
First Post:
2010-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ethanol in the Prevention of Central Venous Catheter Infections
Sponsor:
Hospital General Universitario Gregorio Marañon
Organization:
Study Overview
Official Title:
Clinical Study of Ethanol Lock-therapy in the Prevention of Non-tunnelled, Short Term Central Venous Catheter Associated Infections
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The non significative reduction of CRBSI adverse events,the need for a high frecuency of catheter manipulations
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 \[1-10\].
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).
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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2007-007063-24 | EUDRACT_NUMBER | None | View |