Trial Outcomes & Findings for Ethanol Locks for the Treatment of Central Venous Line Infections (NCT NCT00680459)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

13 participants

Primary outcome timeframe

6 days

Results posted on

2014-03-12

Participant Flow

Participant milestones

Participant milestones
Measure	70% Ethanol Solution 70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.	Heparin Flush heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
Overall Study STARTED	7	6
Overall Study COMPLETED	7	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ethanol Locks for the Treatment of Central Venous Line Infections

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	70% Ethanol Solution n=7 Participants 70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.	Heparin Flush n=6 Participants heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.	Total n=13 Participants Total of all reporting groups
Age, Categorical <=18 years	7 Participants n=99 Participants	6 Participants n=107 Participants	13 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	7.4 years STANDARD_DEVIATION 4.96 • n=99 Participants	6.33 years STANDARD_DEVIATION 4.0 • n=107 Participants	6.9 years STANDARD_DEVIATION 4.4 • n=206 Participants
Sex: Female, Male Female	3 Participants n=99 Participants	2 Participants n=107 Participants	5 Participants n=206 Participants
Sex: Female, Male Male	4 Participants n=99 Participants	4 Participants n=107 Participants	8 Participants n=206 Participants
Region of Enrollment United States	7 participants n=99 Participants	6 participants n=107 Participants	13 participants n=206 Participants

PRIMARY outcome

Timeframe: 6 days

Outcome measures

Outcome measures
Measure	70% Ethanol Solution n=7 Participants 70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.	Heparin Flush n=6 Participants heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
Clearance of Central Venous Line Infection by Day 6 of Study	7 number of CVL cleared	6 number of CVL cleared

SECONDARY outcome

Timeframe: 35 days

Outcome measures

Outcome measures
Measure	70% Ethanol Solution n=7 Participants 70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.	Heparin Flush n=6 Participants heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
Preservation of Central Venous Line (Line Not Requiring Removal) by Day 35 of Study	6 number of lines preserved	6 number of lines preserved

SECONDARY outcome

Timeframe: 35 days

Outcome measures

Outcome measures
Measure	70% Ethanol Solution n=7 Participants 70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.	Heparin Flush n=6 Participants heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
Recurrence of Central Venous Line Infection Within 35 Days of Enrollment	3 # of pts with recurrent infection	1 # of pts with recurrent infection

Adverse Events

70% Ethanol Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Heparin Flush

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

Dr. Christine McKiernan

Baystate Medical Center

Phone: 413-794-5370

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place