Ignite Creation Date:
2024-05-06 @ 12:35 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01603914
Status:
UNKNOWN
Last Update Posted:
2012-08-29
First Post:
2012-05-13
Brief Title:
Central Venous Catheter Replacement Strategies in Adult Patients With Major Burn Injury
Sponsor:
Hospital Universitario Getafe
Organization:
Hospital Universitario Getafe
Study Overview
Official Title:
Comparison of Three Strategies for Changing of Central Venous Catheters in Patients With Serious Burns for the Prevention of Catheter-associated Bacteremia Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2012-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARB
Brief Summary:
The aim of this project is to answer the following questions
To determine the incidence of catheter related bacteremia CRB with three strategies of central venous catheter exchange in critically ill adult patients with major burn and to determine the regimen that will minimize the risk of bacteremia
To determine the incidence rate of catheter colonization in adult patients with major burns
The scientific knowledge to be acquired through this project is of likely benefit to the care of critically ill patients with burns injury as follows
The intention is to improve the outcomes in critically ill patients by minimizing one of the most frequent causes of infection in the Burn Intensive Care Unit those from central venous catheters Decreasing infections will decrease morbidity decrease length of stay decrease costs and decrease mortality
To determine the incidence of catheter related bacteremia CRB with three strategies of central venous catheter exchange in critically ill adult patients with major burn and to determine the regimen that will minimize the risk of bacteremia
To determine the incidence rate of catheter colonization in adult patients with major burns
The scientific knowledge to be acquired through this project is of likely benefit to the care of critically ill patients with burns injury as follows
The intention is to improve the outcomes in critically ill patients by minimizing one of the most frequent causes of infection in the Burn Intensive Care Unit those from central venous catheters Decreasing infections will decrease morbidity decrease length of stay decrease costs and decrease mortality
Detailed Description:
Aim To determine the incidence of catheter-related bacteremia CRB with three primary schedules of central venous catheter exchange in adult critically ill patients with major burn injury
Hypothesis A strategy of catheter exchange according with clinical criteria will result in no more CRB compared with a routine catheter changes without guidewire exchange strategy or frequent guidewire exchange or frequent new-site replacement
Background The intravenous catheter-related bacteremia ICRB is a nosocomial infection affecting patients admitted to intensive care and that leads to increased morbidity Accumulative incidence rates of ICRB are 55 infections per 1000 catheters-day Several strategies have been proposed to decrease of the rate of ICRB in critically ill patients However there is not agreement to recommend a replacement pattern of central venous catheters in adult critically ill patients with major burns as a strategy for the reduction in intravenous catheter-associated bacteremia
Objectives To compare three strategies of replacement from central venous catheters for the prevention of ICRB Find out the risk of mechanical complications associated with each strategy of central venous catheter replacement
Method Randomized multicenter clinical trial single blind to compare three strategies for intravenous catheter replacement in patients with major burns a scheduled wire-guided strategy every six days second a scheduled strategy of replacement every six days in a different punction and third a re-change strategy guided by clinical criteria for suspicion of catheter-associated infection Primary outcome catheter colonization rate and rate of intravenous catheter-associated bacteremia Secondarily we calculate the incidence rate of colonization of central venous catheter and finally we will analyze the associated complications
This project requires enough patients to show a difference between three intervention groups A significant decrease in infection rate would be from the current 20 infections per 1000 catheter days to approximately 15 per 1000 catheter days This would require a minimum of 1000 catheter days per group
Hypothesis A strategy of catheter exchange according with clinical criteria will result in no more CRB compared with a routine catheter changes without guidewire exchange strategy or frequent guidewire exchange or frequent new-site replacement
Background The intravenous catheter-related bacteremia ICRB is a nosocomial infection affecting patients admitted to intensive care and that leads to increased morbidity Accumulative incidence rates of ICRB are 55 infections per 1000 catheters-day Several strategies have been proposed to decrease of the rate of ICRB in critically ill patients However there is not agreement to recommend a replacement pattern of central venous catheters in adult critically ill patients with major burns as a strategy for the reduction in intravenous catheter-associated bacteremia
Objectives To compare three strategies of replacement from central venous catheters for the prevention of ICRB Find out the risk of mechanical complications associated with each strategy of central venous catheter replacement
Method Randomized multicenter clinical trial single blind to compare three strategies for intravenous catheter replacement in patients with major burns a scheduled wire-guided strategy every six days second a scheduled strategy of replacement every six days in a different punction and third a re-change strategy guided by clinical criteria for suspicion of catheter-associated infection Primary outcome catheter colonization rate and rate of intravenous catheter-associated bacteremia Secondarily we calculate the incidence rate of colonization of central venous catheter and finally we will analyze the associated complications
This project requires enough patients to show a difference between three intervention groups A significant decrease in infection rate would be from the current 20 infections per 1000 catheter days to approximately 15 per 1000 catheter days This would require a minimum of 1000 catheter days per group
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISCIII | OTHER_GRANT | Instituto de Salud Carlos III Ministerio de EconomÃa Spain | None |