Trial Outcomes & Findings for Use of a Novel Catheter Lock Solution For Treatment of Hemodialysis Catheter Infections (NCT NCT01483872)
NCT ID: NCT01483872
Last Updated: 2019-09-06
Results Overview
Nine participants signed consent forms, only one randomized. Data was not analyzed.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
9 participants
Primary outcome timeframe
90 days
Results posted on
2019-09-06
Participant Flow
9 patients signed consent forms. Only one developed an active infection and thus underwent randomization.
Participant milestones
| Measure |
NAC/Tigecycline/Heparin Combination Lock Solution
A combination of the above three drugs will form the catheter lock solution that will be instilled into the catheter
NAC/Tigecycline/Heparin combination lock solution
|
Standard Anticoagulant (Heparin or Citrate)
Standard anticoagulant (heparin or citrate)
Standard anticoagulant (Heparin or Citrate)
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
1
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of a Novel Catheter Lock Solution For Treatment of Hemodialysis Catheter Infections
Baseline characteristics by cohort
| Measure |
All Participants
n=9 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: Nine participants signed consent forms, only one randomized. Data was not analyzed.
Nine participants signed consent forms, only one randomized. Data was not analyzed.
Outcome measures
Outcome data not reported
Adverse Events
All Participants
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