Trial Outcomes & Findings for Hub Cleansing to Prevent Hub Infection (NCT NCT01563406)
NCT ID: NCT01563406
Last Updated: 2016-04-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
149 participants
Primary outcome timeframe
15 months
Results posted on
2016-04-18
Participant Flow
140 participants were recruited through 149 separate medical intensive care unit (MICU) admissions. Each MICU admission is treated as a separate enrollment.
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.
Participant milestones
| Measure |
Alcohol, 15 Second Scrub
\- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec
|
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
|
Alcohol, 5 Second Scrub
\- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
|
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
60
|
30
|
30
|
29
|
|
Overall Study
COMPLETED
|
60
|
30
|
30
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hub Cleansing to Prevent Hub Infection
Baseline characteristics by cohort
| Measure |
Alcohol, 15 Second Scrub
n=60 Participants
\- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec
|
Chlorhexidine+Alcohol, 15 Second Scrub
n=30 Participants
\- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec
|
Alcohol, 5 Second Scrub
n=30 Participants
\- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
|
Chlorhexidine+Alcohol, 5 Second Scrub
n=29 Participants
\- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 17 • n=5 Participants
|
61 years
STANDARD_DEVIATION 12 • n=7 Participants
|
53 years
STANDARD_DEVIATION 17 • n=5 Participants
|
59 years
STANDARD_DEVIATION 17 • n=4 Participants
|
59 years
STANDARD_DEVIATION 16 • n=21 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
67 Participants
n=21 Participants
|
|
BMI
|
29 kg/m^2
STANDARD_DEVIATION 9 • n=5 Participants
|
31 kg/m^2
STANDARD_DEVIATION 11 • n=7 Participants
|
30 kg/m^2
STANDARD_DEVIATION 14 • n=5 Participants
|
32 kg/m^2
STANDARD_DEVIATION 13 • n=4 Participants
|
30 kg/m^2
STANDARD_DEVIATION 11 • n=21 Participants
|
|
Mechanical ventilation
Yes
|
37 participants
n=5 Participants
|
20 participants
n=7 Participants
|
24 participants
n=5 Participants
|
19 participants
n=4 Participants
|
100 participants
n=21 Participants
|
|
Mechanical ventilation
No
|
23 participants
n=5 Participants
|
10 participants
n=7 Participants
|
6 participants
n=5 Participants
|
10 participants
n=4 Participants
|
49 participants
n=21 Participants
|
|
Decubitus ulcer
Yes
|
24 participants
n=5 Participants
|
11 participants
n=7 Participants
|
8 participants
n=5 Participants
|
9 participants
n=4 Participants
|
52 participants
n=21 Participants
|
|
Decubitus ulcer
No
|
36 participants
n=5 Participants
|
19 participants
n=7 Participants
|
22 participants
n=5 Participants
|
20 participants
n=4 Participants
|
97 participants
n=21 Participants
|
|
Diarrhea
Yes
|
20 participants
n=5 Participants
|
16 participants
n=7 Participants
|
13 participants
n=5 Participants
|
12 participants
n=4 Participants
|
61 participants
n=21 Participants
|
|
Diarrhea
No
|
40 participants
n=5 Participants
|
14 participants
n=7 Participants
|
17 participants
n=5 Participants
|
17 participants
n=4 Participants
|
88 participants
n=21 Participants
|
|
Diabetes
Yes
|
21 participants
n=5 Participants
|
13 participants
n=7 Participants
|
8 participants
n=5 Participants
|
7 participants
n=4 Participants
|
49 participants
n=21 Participants
|
|
Diabetes
No
|
39 participants
n=5 Participants
|
17 participants
n=7 Participants
|
22 participants
n=5 Participants
|
22 participants
n=4 Participants
|
100 participants
n=21 Participants
|
|
Heart disease
Yes
|
32 participants
n=5 Participants
|
16 participants
n=7 Participants
|
12 participants
n=5 Participants
|
21 participants
n=4 Participants
|
81 participants
n=21 Participants
|
|
Heart disease
No
|
28 participants
n=5 Participants
|
14 participants
n=7 Participants
|
18 participants
n=5 Participants
|
8 participants
n=4 Participants
|
68 participants
n=21 Participants
|
|
Pulmonary Disease
Yes
|
14 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
36 participants
n=21 Participants
|
|
Pulmonary Disease
No
|
46 participants
n=5 Participants
|
24 participants
n=7 Participants
|
22 participants
n=5 Participants
|
21 participants
n=4 Participants
|
113 participants
n=21 Participants
|
|
Liver disease
Yes
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
14 participants
n=21 Participants
|
|
Liver disease
No
|
55 participants
n=5 Participants
|
26 participants
n=7 Participants
|
28 participants
n=5 Participants
|
26 participants
n=4 Participants
|
135 participants
n=21 Participants
|
|
Central venous catheter (CVC) type
Triple lumen
|
135 hubs
n=5 Participants
|
69 hubs
n=7 Participants
|
61 hubs
n=5 Participants
|
86 hubs
n=4 Participants
|
351 hubs
n=21 Participants
|
|
Central venous catheter (CVC) type
PICC
|
59 hubs
n=5 Participants
|
33 hubs
n=7 Participants
|
40 hubs
n=5 Participants
|
26 hubs
n=4 Participants
|
158 hubs
n=21 Participants
|
|
Anatomic location of CVC
Internal/external jugular
|
102 hubs
n=5 Participants
|
70 hubs
n=7 Participants
|
65 hubs
n=5 Participants
|
58 hubs
n=4 Participants
|
295 hubs
n=21 Participants
|
|
Anatomic location of CVC
Basilic/cephalic/brachial
|
51 hubs
n=5 Participants
|
21 hubs
n=7 Participants
|
30 hubs
n=5 Participants
|
20 hubs
n=4 Participants
|
122 hubs
n=21 Participants
|
|
Anatomic location of CVC
Femoral
|
21 hubs
n=5 Participants
|
11 hubs
n=7 Participants
|
6 hubs
n=5 Participants
|
21 hubs
n=4 Participants
|
59 hubs
n=21 Participants
|
|
Anatomic location of CVC
Subclavian
|
18 hubs
n=5 Participants
|
0 hubs
n=7 Participants
|
0 hubs
n=5 Participants
|
13 hubs
n=4 Participants
|
31 hubs
n=21 Participants
|
|
Anatomic location of CVC
Unknown
|
2 hubs
n=5 Participants
|
0 hubs
n=7 Participants
|
0 hubs
n=5 Participants
|
0 hubs
n=4 Participants
|
2 hubs
n=21 Participants
|
|
Time hub in place
|
95 hours
STANDARD_DEVIATION 27 • n=5 Participants
|
101 hours
STANDARD_DEVIATION 41 • n=7 Participants
|
100 hours
STANDARD_DEVIATION 33 • n=5 Participants
|
94 hours
STANDARD_DEVIATION 25 • n=4 Participants
|
97 hours
STANDARD_DEVIATION 31 • n=21 Participants
|
|
No. hubs per patient
|
3 hubs per patient
n=5 Participants
|
3 hubs per patient
n=7 Participants
|
3 hubs per patient
n=5 Participants
|
3 hubs per patient
n=4 Participants
|
3 hubs per patient
n=21 Participants
|
PRIMARY outcome
Timeframe: 15 monthsPopulation: 140 participants were recruited through 149 separate medical intensive care unit (MICU) admissions. Each MICU admission is treated as a separate enrollment.
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.
Outcome measures
| Measure |
Alcohol, 15 Second Scrub
n=194 Hubs
Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec.
|
Chlorhexidine+Alcohol, 15 Second Scrub
n=102 Hubs
Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec.
|
Alcohol, 5 Second Scrub
n=101 Hubs
Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
|
Chlorhexidine+Alcohol, 5 Second Scrub
n=112 Hubs
Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec.
|
|---|---|---|---|---|
|
Number of Central Venous Catheter Hubs With Internal Contamination
|
42 contaminated hubs
|
18 contaminated hubs
|
39 contaminated hubs
|
14 contaminated hubs
|
SECONDARY outcome
Timeframe: 10 monthsPopulation: Unable to collect a sufficient number of catheter tips to analyze. Therefore, this outcome was dropped early in the study.
This will be a qualitative measure for central venous catheter tip contamination. The results will be reported as "yes" or "no".
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 15 monthsThis 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.
Outcome measures
| Measure |
Alcohol, 15 Second Scrub
n=194 Hubs
Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec.
|
Chlorhexidine+Alcohol, 15 Second Scrub
n=102 Hubs
Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec.
|
Alcohol, 5 Second Scrub
n=101 Hubs
Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
|
Chlorhexidine+Alcohol, 5 Second Scrub
n=112 Hubs
Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec.
|
|---|---|---|---|---|
|
Median Number of Microbial Colony Forming Units Per Hub Interior
|
0 colony forming units (CFU) per hub
Interval 0.0 to 0.0
|
0 colony forming units (CFU) per hub
Interval 0.0 to 0.0
|
0 colony forming units (CFU) per hub
Interval 0.0 to 40.0
|
0 colony forming units (CFU) per hub
Interval 0.0 to 0.0
|
Adverse Events
Alcohol, 15 Second Scrub
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Chlorhexidine+Alcohol, 15 Second Scrub
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Alcohol, 5 Second Scrub
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Chlorhexidine+Alcohol, 5 Second Scrub
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place