Trial Outcomes & Findings for Pediatric Ethanol Lock Therapy Study. (NCT NCT00948441)
NCT ID: NCT00948441
Last Updated: 2016-04-18
Results Overview
For the purpose of this study, episodes of catheter related blood stream infections were considered as the primary outcome measure. An episode of infection was defined as more than one positive blood culture obtained from the catheter requiring antibiotic therapy. Each episode after enrollment was recorded in its appropriate study period: ethanol lock, placebo lock, or washout period. If a patient had a catheter related blood stream infections, the study locks were held until after the number of days in each period was calculated as the number of days not on antibiotic therapy.
COMPLETED
NA
16 participants
7 months per study patient
2016-04-18
Participant Flow
Children at our hospital with central venous access for parental nutrition and at least 3 CRBSI in the past 6 months were recruited. Patients had to be at least 6 months old and \<21 years and be able to have a minimal dwell time of 4 hours. Exclusion criteria: known immunodeficiency or allergies to ethanol or heparin.
Randomized to one of two study groups. group 1 - ethanol lock followed by washout period followed by heparin lock. group 2 - heparin lock followed by washout period followed by ethanol lock.
Participant milestones
| Measure |
25% Ethanol/Washout/Heparin
First 25% ethanol, then Washout, then heparin
|
Heparin Lock/Washout/25% Ethanol
First Heparin lock, then washout period, then 25% ethanol lock
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
7
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
25% Ethanol/Washout/Heparin
First 25% ethanol, then Washout, then heparin
|
Heparin Lock/Washout/25% Ethanol
First Heparin lock, then washout period, then 25% ethanol lock
|
|---|---|---|
|
Overall Study
no longer meet inclusion criteria
|
1
|
4
|
Baseline Characteristics
Pediatric Ethanol Lock Therapy Study.
Baseline characteristics by cohort
| Measure |
Group 1
n=7 Participants
25% ethanol x12 weeks; washout x4 weeks; heparin x12 weeks
|
Group 2
n=4 Participants
Heparin x12 weeks; washout x4 weeks; 25% ethanol x 12 weeks
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
4.99 years
n=5 Participants
|
2 years
n=7 Participants
|
4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 months per study patientPopulation: This was a crossover study. Each participant served as their own control. Infections in each time period of the study were compared. Infections with using ethanol locks and infections while using heparin locks.
For the purpose of this study, episodes of catheter related blood stream infections were considered as the primary outcome measure. An episode of infection was defined as more than one positive blood culture obtained from the catheter requiring antibiotic therapy. Each episode after enrollment was recorded in its appropriate study period: ethanol lock, placebo lock, or washout period. If a patient had a catheter related blood stream infections, the study locks were held until after the number of days in each period was calculated as the number of days not on antibiotic therapy.
Outcome measures
| Measure |
Infections While Using Ethanol Lock
n=11 Participants
25% ethanol x 12 weeks
25% ethanol: Study Lock -25% Ethanol- The ethanol lock therapy consists of placing up to 2.3 ml of 25% ethanol into the central venous catheter and allowing it to dwell for 4 to 12 hours per day.
|
Infections While Using Heparin Lock
n=11 Participants
Heparin lock x 12 weeks
heparin lock: Placebo Lock - Heparin - These will be prepared in a sterile fashion in the Pharmacy of Children's Hospital of Pittsburgh in 10 day supplies as 1ml lock syringes utilizing 100 units/ml if the central venous catheter is accessed once daily and 10 units/ml if accessed more than once daily. The lock solution was instilled and allowed to dwell for 4 to 12 hours.
|
|---|---|---|
|
Number of Episodes of Catheter Related Blood Stream Infections in Each Study Period.
|
6.59 number of CRBSI per 1000 catheter days
|
25.90 number of CRBSI per 1000 catheter days
|
SECONDARY outcome
Timeframe: 7 months per study patientPopulation: collected adverse events during each time period
collection of adverse events and safety information. Each participant was contacted either at a clinical visit or by phone every two weeks while enrolled in the study.
Outcome measures
| Measure |
Infections While Using Ethanol Lock
n=11 Participants
25% ethanol x 12 weeks
25% ethanol: Study Lock -25% Ethanol- The ethanol lock therapy consists of placing up to 2.3 ml of 25% ethanol into the central venous catheter and allowing it to dwell for 4 to 12 hours per day.
|
Infections While Using Heparin Lock
n=11 Participants
Heparin lock x 12 weeks
heparin lock: Placebo Lock - Heparin - These will be prepared in a sterile fashion in the Pharmacy of Children's Hospital of Pittsburgh in 10 day supplies as 1ml lock syringes utilizing 100 units/ml if the central venous catheter is accessed once daily and 10 units/ml if accessed more than once daily. The lock solution was instilled and allowed to dwell for 4 to 12 hours.
|
|---|---|---|
|
Safety, Side Effects
|
11 participants
|
11 participants
|
Adverse Events
Ethanol Lock
Heparin Lock
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