Trial Outcomes & Findings for Prophylactic Antimicrobial Catheter Lock (NCT NCT00571259)
NCT ID: NCT00571259
Last Updated: 2021-09-22
Results Overview
Positive blood cultures in a patient whose vascular access is a central venous catheter without another obvious source of infection
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
303 participants
Primary outcome timeframe
5 years
Results posted on
2021-09-22
Participant Flow
Participant milestones
| Measure |
1: Heparin Lock
Dialysis Catheter locked with heparin 1,000 units/mL.
Heparin 1000U/mL: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis
|
2: Gentamicin Lock
Dialysis Catheter locked with gentamicin 320 micrograms/mL in sodium citrate 4%.
4% Sodium Citrate with Gentamicin 320 mcg/mL: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis
|
|---|---|---|
|
Overall Study
STARTED
|
148
|
155
|
|
Overall Study
COMPLETED
|
4
|
14
|
|
Overall Study
NOT COMPLETED
|
144
|
141
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prophylactic Antimicrobial Catheter Lock
Baseline characteristics by cohort
| Measure |
1: Heparin Lock
n=148 Participants
Dialysis catheter locked with heparin 1,000 units/mL post-dialysis.
Heparin 1000U/mL: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis
|
2: Gentamicin Lock
n=155 Participants
Dialysis catheter locked with gentamicin 320 micrograms/mL in sodium citrate 4% post-dialysis.
4% Sodium Citrate with Gentamicin 320 mcg/mL: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis
|
Total
n=303 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.8 years
STANDARD_DEVIATION 16.8 • n=5 Participants
|
63.4 years
STANDARD_DEVIATION 15.6 • n=7 Participants
|
63.1 years
STANDARD_DEVIATION 14.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
148 participants
n=5 Participants
|
155 participants
n=7 Participants
|
303 participants
n=5 Participants
|
|
Diabetes
|
86 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Dialysis vintage in Months
|
44.3 months
n=5 Participants
|
42.4 months
n=7 Participants
|
43.32 months
n=5 Participants
|
|
Incident Catheters
|
15 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Catheter site
Internal Jugular
|
104 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
217 Participants
n=5 Participants
|
|
Catheter site
External Jugular
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Catheter site
Femoral
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Catheter site
Subclavian
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Catheter site
Unknown
|
25 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Episodes of catheter related infections in each group throughout the study.
Positive blood cultures in a patient whose vascular access is a central venous catheter without another obvious source of infection
Outcome measures
| Measure |
1: Heparin Lock
n=148 Participants
Dialysis Catheter locked with heparin 1,000 units/mL in a volume sufficient to fill the catheter length and instilled in both catheter ports post-dialysis.
Heparin 1000U/mL: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis
|
2: Gentamicin Lock
n=155 Participants
Dialysis Catheter locked with gentamicin 320 micrograms/mL in sodium citrate 4% in a volume sufficient to fill the catheter length and instilled in both catheter ports post-dialysis.
4% Sodium Citrate with Gentamicin 320 mcg/mL: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis
|
|---|---|---|
|
Rate of Device-related Bacteremia
|
30 Number of infections
|
11 Number of infections
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: tPA use/1,000 catheter-days
The rate of thrombolytic agent use required to maintain blood flow adequate for dialysis was used as an objective measure of clinically significant catheter clotting.
Outcome measures
| Measure |
1: Heparin Lock
n=148 Participants
Dialysis Catheter locked with heparin 1,000 units/mL in a volume sufficient to fill the catheter length and instilled in both catheter ports post-dialysis.
Heparin 1000U/mL: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis
|
2: Gentamicin Lock
n=155 Participants
Dialysis Catheter locked with gentamicin 320 micrograms/mL in sodium citrate 4% in a volume sufficient to fill the catheter length and instilled in both catheter ports post-dialysis.
4% Sodium Citrate with Gentamicin 320 mcg/mL: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis
|
|---|---|---|
|
Rate of Catheter Clotting Measured as Requirement for tPA Usage to Maintain Blood Flow
|
3.42 tPA use/1,000 catheter-days
|
2.36 tPA use/1,000 catheter-days
|
Adverse Events
1: Heparin Lock
Serious events: 25 serious events
Other events: 0 other events
Deaths: 25 deaths
2: Gentamicin Lock
Serious events: 27 serious events
Other events: 0 other events
Deaths: 27 deaths
Serious adverse events
| Measure |
1: Heparin Lock
n=148 participants at risk
Dialysis Catheter locked with heparin 1,000 units/mL.
Heparin 1000U/mL: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis
|
2: Gentamicin Lock
n=155 participants at risk
Dialysis Catheter locked with gentamicin 320 micrograms/mL in sodium citrate 4%.
4% Sodium Citrate with Gentamicin 320 mcg/mL: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis
|
|---|---|---|
|
Renal and urinary disorders
ESRD Related Death
|
16.9%
25/148 • Number of events 25 • 5 years
|
17.4%
27/155 • Number of events 27 • 5 years
|
Other adverse events
Adverse event data not reported
Additional Information
Veronica Legg, MS: Director of Research Business
Satellite Healthcare, Inc.
Phone: 360-607-6892
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place