Bacteremia
Conditions
Keywords
Needleless connectors, catheter hubs
Brief summary
Central venous catheter infections are common preventable adverse events among hospital patients. Microbes may enter catheter hubs, also known as needleless connectors, and result in downstream contamination. This study aims to compare alcohol disinfection of catheter hubs to disinfection with chlorhexidine gluconate in alcohol, which has been proven to be a superior disinfectant at the site of central venous catheter insertion. Scrub duration of central venous catheter hubs will also be evaluated.
Detailed description
A prospective randomized blinded crossover clinical trial will be performed in the medical intensive care unit at Rush University Medical Center. The intensive care unit will be divided into two regions (A&B). Hub disinfectants and duration of disinfection will be randomly assigned to these regions. After 1/2 of the study period, the agents will crossover, but the duration of scrubbing will remain the same, analogous to a 2 by 2 factorial design. Our primary endpoint will be internal contamination of hubs and catheters. In February 2012 it was determined that the supplier of chlorhexidine and alcohol pads could not completely blind each pad. It was decided that a plain white sticker would be affixed to the front of each pad, but the safety information on the back of each pad would remain visible. 3/27/12-Internal hub contamination (yes/no)was clarified as the primary outcome. On 5/10/12 a new sample size calculation adjusted the hub sample size needed to power the main effects based on more accurate information regarding the expected hub contamination rate. The expected hub contamination rate changed because of the more sensitive hub culture method that was adopted before the study began. This more sensitive method also allowed for a new secondary outcome of number of microbial colony forming units per hub. The first crossover time selected was 6/11/12, prior to the midpoint of the study. This was done to try to improve a large imbalance in the group sizes. On 6/11/12 a hold was placed on the catheter tip component of the study, because of an inability to collect tips. On 8/7/12 the catheter tip outcome was dropped because of an inability to collect tips. On 1/11/13 a second crossover was implemented in an effort to balance the sizes of the study groups.
Interventions
70% isopropyl alcohol pads will be used to disinfect catheter hubs prior to accessing central venous catheters for the other half of the study period.
OTHER15 second scrub
Scrub catheter hubs for 15 seconds before every access.
OTHER5 second scrub
Scrub catheter hubs for 15 seconds before every access.
DRUG3.15% chlorhexidine/70% isopropyl alcohol
3.15% chlorhexidine gluconate in 70% isopropyl alcohol pads will be used to disinfect catheter hubs prior to accessing central venous catheters during half of the study period.
Sponsors
Centers for Disease Control and Prevention
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Medical intensive care unit patients with non-tunneled central venous catheters
Exclusion criteria
* Dialysis catheters * Antibiotic-impregnated catheters * Introducer sheaths * Tunneled catheters
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Central Venous Catheter Hubs With Internal Contamination | 15 months | This will be a qualitative outcome. It will be reported as yes or no for central venous catheter hub internal contamination. The number of hubs with internal contamination will be compared for the four study arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Contaminated Central Venous Catheter Tips | 10 months | This will be a qualitative measure for central venous catheter tip contamination. The results will be reported as yes or no. |
| Median Number of Microbial Colony Forming Units Per Hub Interior | 15 months | This will be a quantitative outcome. It will be reported as the median number of microbial colony forming units isolated per hub interior. The median number of microbial colony forming units isolated per hub interior will be compared for the four study arms. |
Countries
United States
Participant flow
Recruitment details
140 participants were recruited through 149 separate medical intensive care unit (MICU) admissions. Each MICU admission is treated as a separate enrollment.
Pre-assignment details
Two separate wings of a 24-bed MICU were randomized to receive different intervention sequences. Wing A was assigned to a 15 sec scrub of 1) Alcohol; 2) chlorhexidine gluconate (CHG)+Alcohol; 3) Alcohol; and Wing B was assigned to a 5 sec scrub of 1) CHG+Alcohol; 2) Alcohol; 3) CHG+Alcohol.
Participants by arm
| Arm | Count |
|---|---|
| Alcohol, 15 Second Scrub \- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec | 60 |
| Chlorhexidine+Alcohol, 15 Second Scrub \- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec | 30 |
| Alcohol, 5 Second Scrub \- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec. | 30 |
| Chlorhexidine+Alcohol, 5 Second Scrub \- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec | 29 |
| Total | 149 |
Baseline characteristics
| Characteristic | Chlorhexidine+Alcohol, 15 Second Scrub | Total | Chlorhexidine+Alcohol, 5 Second Scrub | Alcohol, 5 Second Scrub | Alcohol, 15 Second Scrub |
|---|---|---|---|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 12 | 59 years STANDARD_DEVIATION 16 | 59 years STANDARD_DEVIATION 17 | 53 years STANDARD_DEVIATION 17 | 60 years STANDARD_DEVIATION 17 |
| Anatomic location of CVC Basilic/cephalic/brachial | 21 hubs | 122 hubs | 20 hubs | 30 hubs | 51 hubs |
| Anatomic location of CVC Femoral | 11 hubs | 59 hubs | 21 hubs | 6 hubs | 21 hubs |
| Anatomic location of CVC Internal/external jugular | 70 hubs | 295 hubs | 58 hubs | 65 hubs | 102 hubs |
| Anatomic location of CVC Subclavian | 0 hubs | 31 hubs | 13 hubs | 0 hubs | 18 hubs |
| Anatomic location of CVC Unknown | 0 hubs | 2 hubs | 0 hubs | 0 hubs | 2 hubs |
| BMI | 31 kg/m^2 STANDARD_DEVIATION 11 | 30 kg/m^2 STANDARD_DEVIATION 11 | 32 kg/m^2 STANDARD_DEVIATION 13 | 30 kg/m^2 STANDARD_DEVIATION 14 | 29 kg/m^2 STANDARD_DEVIATION 9 |
| Central venous catheter (CVC) type PICC | 33 hubs | 158 hubs | 26 hubs | 40 hubs | 59 hubs |
| Central venous catheter (CVC) type Triple lumen | 69 hubs | 351 hubs | 86 hubs | 61 hubs | 135 hubs |
| Decubitus ulcer No | 19 participants | 97 participants | 20 participants | 22 participants | 36 participants |
| Decubitus ulcer Yes | 11 participants | 52 participants | 9 participants | 8 participants | 24 participants |
| Diabetes No | 17 participants | 100 participants | 22 participants | 22 participants | 39 participants |
| Diabetes Yes | 13 participants | 49 participants | 7 participants | 8 participants | 21 participants |
| Diarrhea No | 14 participants | 88 participants | 17 participants | 17 participants | 40 participants |
| Diarrhea Yes | 16 participants | 61 participants | 12 participants | 13 participants | 20 participants |
| Heart disease No | 14 participants | 68 participants | 8 participants | 18 participants | 28 participants |
| Heart disease Yes | 16 participants | 81 participants | 21 participants | 12 participants | 32 participants |
| Liver disease No | 26 participants | 135 participants | 26 participants | 28 participants | 55 participants |
| Liver disease Yes | 4 participants | 14 participants | 3 participants | 2 participants | 5 participants |
| Mechanical ventilation No | 10 participants | 49 participants | 10 participants | 6 participants | 23 participants |
| Mechanical ventilation Yes | 20 participants | 100 participants | 19 participants | 24 participants | 37 participants |
| No. hubs per patient | 3 hubs per patient | 3 hubs per patient | 3 hubs per patient | 3 hubs per patient | 3 hubs per patient |
| Pulmonary Disease No | 24 participants | 113 participants | 21 participants | 22 participants | 46 participants |
| Pulmonary Disease Yes | 6 participants | 36 participants | 8 participants | 8 participants | 14 participants |
| Sex: Female, Male Female | 16 Participants | 82 Participants | 17 Participants | 14 Participants | 35 Participants |
| Sex: Female, Male Male | 14 Participants | 67 Participants | 12 Participants | 16 Participants | 25 Participants |
| Time hub in place | 101 hours STANDARD_DEVIATION 41 | 97 hours STANDARD_DEVIATION 31 | 94 hours STANDARD_DEVIATION 25 | 100 hours STANDARD_DEVIATION 33 | 95 hours STANDARD_DEVIATION 27 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 60 | 0 / 30 | 0 / 30 | 0 / 29 |
| serious Total, serious adverse events | 0 / 60 | 0 / 30 | 0 / 30 | 0 / 29 |
Outcome results
Primary
Number of Central Venous Catheter Hubs With Internal Contamination
This will be a qualitative outcome. It will be reported as yes or no for central venous catheter hub internal contamination. The number of hubs with internal contamination will be compared for the four study arms.
Time frame: 15 months
Population: 140 participants were recruited through 149 separate medical intensive care unit (MICU) admissions. Each MICU admission is treated as a separate enrollment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alcohol, 15 Second Scrub | Number of Central Venous Catheter Hubs With Internal Contamination | 42 contaminated hubs |
| Chlorhexidine+Alcohol, 15 Second Scrub | Number of Central Venous Catheter Hubs With Internal Contamination | 18 contaminated hubs |
| Alcohol, 5 Second Scrub | Number of Central Venous Catheter Hubs With Internal Contamination | 39 contaminated hubs |
| Chlorhexidine+Alcohol, 5 Second Scrub | Number of Central Venous Catheter Hubs With Internal Contamination | 14 contaminated hubs |
Secondary
Median Number of Microbial Colony Forming Units Per Hub Interior
This will be a quantitative outcome. It will be reported as the median number of microbial colony forming units isolated per hub interior. The median number of microbial colony forming units isolated per hub interior will be compared for the four study arms.
Time frame: 15 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Alcohol, 15 Second Scrub | Median Number of Microbial Colony Forming Units Per Hub Interior | 0 colony forming units (CFU) per hub |
| Chlorhexidine+Alcohol, 15 Second Scrub | Median Number of Microbial Colony Forming Units Per Hub Interior | 0 colony forming units (CFU) per hub |
| Alcohol, 5 Second Scrub | Median Number of Microbial Colony Forming Units Per Hub Interior | 0 colony forming units (CFU) per hub |
| Chlorhexidine+Alcohol, 5 Second Scrub | Median Number of Microbial Colony Forming Units Per Hub Interior | 0 colony forming units (CFU) per hub |
Secondary
Number of Contaminated Central Venous Catheter Tips
This will be a qualitative measure for central venous catheter tip contamination. The results will be reported as yes or no.
Time frame: 10 months
Population: Unable to collect a sufficient number of catheter tips to analyze. Therefore, this outcome was dropped early in the study.