Catheter-related Bloodstream Infection
Conditions
Brief summary
We proposed to perform a prospective randomized controlled trial to study the effect of the use of a commercially-available chlorhexidine-impregnated sponge (Biopatch) as part of central venous catheter care on catheter-related bloodstream infections among patients in two Barnes-Jewish Hospital ICUs.
Detailed description
At the time of the inception of this study, there were no published randomized controlled trial on the efficacy of the Biopatch in reducing bloodstream infections. Preliminary data has shown that the Biopatch decreases colonization of the catheter exit site and thereby decrease bloodstream infections but this was at that time only theoretical.
Interventions
Patients in the treatment arm will have the Biopatch incorporated into their catheter care protocol. ICU nurses were instructed on the proper use of this novel dressing/sponge. Catheter dressing changes will only be done every 7 days unless there is visible blood, soiling underneath the dressing, or if the dressing comes off.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients who are admitted to the ICU with a central venous catheter (i.e. triple lumen catheters, quadruple lumen catheters, percutaneously inserted central catheters, arterial catheters, intraaortic balloon pumps, Swan-Ganz catheters).
Exclusion criteria
* patients who are not enrolled into the trial within 7 days of having the catheter being placed and patients who are allergic to chlorhexidine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Catheter Related Bloodstream Infections (BSI) /1000 Catheter Days in Both Arms | 2 years | The outcome measure is the number of episodes of bloodstream infections (BSI) divided by the catheter days at risk multiplied by 1000 for standardization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Sepsis Episodes/Per 1000 Catheter Days | 2 years | This measure is a combination of patients with positive blood cultures (BSI) and patients who had signs and symptoms of sepsis but with negative blood cultures. These patients still required treatment with antibiotics. |
Countries
United States
Participant flow
Recruitment details
The patients were recruited from two ICUs at BJH. The nurse was asked to page the research coordinators on patients who were scheduled to have a central venous catheter placed for IV access.
Pre-assignment details
Patients or family member authorized to consent for the patient (if the patient was not competent to consent to the study) were approached by study personnel for inclusion into the study. Written informed consent was obtained for all subjects and randomization group was assigned in blocks of 4.
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Patients in this arm will continue to get the standard catheter care protocol without the use of the chlorhexidine-impregnated foam dressing. | 534 |
| Chlorhexidine-impregnated Foam Dressing Patients in this group had the Biopatch applied on the catheter exit site after insertion of the catheter. Dressings were changed every 7 days along with the Biopatch after the skin was cleaned with a chlorhexidine-alcohol antiseptic solution. Dressings were assessed daily and changed if they were soiled, non-intact, or bloody before the 7-day period was up. | 554 |
| Total | 1,088 |
Baseline characteristics
| Characteristic | Standard of Care | Chlorhexidine-impregnated Foam Dressing | Total |
|---|---|---|---|
| Age Continuous | 58.26 years STANDARD_DEVIATION 16.88 | 58.70 years STANDARD_DEVIATION 16.83 | 58.47 years STANDARD_DEVIATION 16.84 |
| Region of Enrollment United States | 534 participants | 554 participants | 1088 participants |
| Sex: Female, Male Female | 304 Participants | 325 Participants | 629 Participants |
| Sex: Female, Male Male | 230 Participants | 229 Participants | 459 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 534 | 0 / 554 |
| serious Total, serious adverse events | 0 / 534 | 0 / 554 |
Outcome results
Primary
The Number of Catheter Related Bloodstream Infections (BSI) /1000 Catheter Days in Both Arms
The outcome measure is the number of episodes of bloodstream infections (BSI) divided by the catheter days at risk multiplied by 1000 for standardization
Time frame: 2 years
Population: Based on previous data (unpublished),there would be a 60% reduction in the incidence of bloodstream infections-- the primary outcome. The number of patients included in this study had a large enough sample size to show a statistical difference.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care | The Number of Catheter Related Bloodstream Infections (BSI) /1000 Catheter Days in Both Arms | 4.74 BSIs /1000 catheter days |
| Chlorhexidine Impregnated Sponge | The Number of Catheter Related Bloodstream Infections (BSI) /1000 Catheter Days in Both Arms | 4.72 BSIs /1000 catheter days |
Comparison: The null hypothesis is that the Bloostream infection per 1000 catheter days will be similar in both groups. In 2004, 6122 catheter days occurred in by both ICUs. If 15% of these were excluded, then 5203 catheter days/year will be eligible for analysis. The difference in infection rates will reach statistical significance at 12 months with a P-value of 0.04. At 24 months, the P-value will be more significant at 0.006.p-value: 0.0595% CI: [0.24, 0.9]Cochran-Mantel-Haenszel
Secondary
Clinical Sepsis Episodes/Per 1000 Catheter Days
This measure is a combination of patients with positive blood cultures (BSI) and patients who had signs and symptoms of sepsis but with negative blood cultures. These patients still required treatment with antibiotics.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care | Clinical Sepsis Episodes/Per 1000 Catheter Days | 7.8 sepsis episodes/1000 catheter days |
| Chlorhexidine Impregnated Sponge | Clinical Sepsis Episodes/Per 1000 Catheter Days | 8.5 sepsis episodes/1000 catheter days |