Trial Outcomes & Findings for 8.4% Sodium Bicarbonate Locks in Intestinal Failure (NCT NCT05813535)
NCT ID: NCT05813535
Last Updated: 2026-05-28
Results Overview
Number of infections per 1000 catheter days
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Through study completion, an average of 1 year
Results posted on
2026-05-28
Participant Flow
Participant milestones
| Measure |
Sodium Bicarb Lock
Sodium bicarb lock
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention
n=6 Participants
8.4% sodium bicarb locks
|
|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=6 Participants
|
|
Age, Continuous
|
12.3 years
n=6 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=6 Participants
|
|
Catheter related blood stream infection rate
|
3.0 infections per 1000 catheter days
n=6 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 1 yearNumber of infections per 1000 catheter days
Outcome measures
| Measure |
Baseline
n=6 Participants
Heparin locks
|
Sodium Bicarb Locks
n=6 Participants
Sodium bicarb locks
|
|---|---|---|
|
Rate of Catheter Related Bloodstream Infections
|
8.2 infections per 1000 catheter days
Interval 1.4 to 14.3
|
3.0 infections per 1000 catheter days
Interval 0.0 to 11.1
|
Adverse Events
Heparin Locks
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sodium Bicarb Locks
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