Trial Outcomes & Findings for Prophylactic Ethanol Lock Therapy (ELT) in Patients on Home Parenteral Nutrition (NCT NCT02227329)

Results Overview

The most common complication in parenteral nutrition is catheter-related blood stream infection (CRBSI), which can lean to increased morbidity, mortality, and prolonged hospitalizations. CRBSI was defined as bacteremia or fungemia in a patient who had an intravascular device and \>1 positive blood culture result obtained from the peripheral vein, clinical manifestations of infection (e.g., fever, chills, and/or hypotension), and no apparent source for blood stream infection other than the central venous catheter.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

39 participants

Primary outcome timeframe

1 year

Results posted on

2017-12-12

Participant Flow

This clinical trial was carried out from July 2014 to April 2016 at the Mayo Clinic in Rochester, Minnesota.

39 subjects were consented, but one subject was excluded after enrollment due to incompatibility with ongoing treatment (ongoing metronidazole use).

Participant milestones

Participant milestones
Measure	Ethanol Lock and Normal Saline All patients randomized to the ELT group will receive 3ml of 70% ethanol and saline flush.	Heparin and Normal Saline All patients randomized to this group will receive Heparin lock (3 mL of 100 U/ml heparin) + saline infusion (current standard of care).
Overall Study STARTED	18	20
Overall Study COMPLETED	18	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prophylactic Ethanol Lock Therapy (ELT) in Patients on Home Parenteral Nutrition

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ethanol Lock and Normal Saline n=18 Participants All patients randomized to the ELT group will receive 3ml of 70% ethanol and saline flush.	Heparin and Normal Saline n=20 Participants All patients randomized to this group will receive Heparin lock (3 mL of 100 U/ml heparin) + saline infusion (current standard of care).	Total n=38 Participants Total of all reporting groups
Age, Continuous	49 years STANDARD_DEVIATION 16 • n=5 Participants	52 years STANDARD_DEVIATION 16 • n=7 Participants	51 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	14 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	18 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

The most common complication in parenteral nutrition is catheter-related blood stream infection (CRBSI), which can lean to increased morbidity, mortality, and prolonged hospitalizations. CRBSI was defined as bacteremia or fungemia in a patient who had an intravascular device and \>1 positive blood culture result obtained from the peripheral vein, clinical manifestations of infection (e.g., fever, chills, and/or hypotension), and no apparent source for blood stream infection other than the central venous catheter.

Outcome measures

Outcome measures
Measure	Ethanol Lock and Normal Saline n=18 Participants All patients randomized to the ELT group will receive 3ml of 70% ethanol and saline flush.	Heparin and Normal Saline n=20 Participants All patients randomized to this group will receive Heparin lock (3 mL of 100 U/ml heparin) + saline infusion (current standard of care).
Number of Catheter-Related Blood Stream Infections	4 infections	1 infections

Adverse Events

Ethanol Lock and Normal Saline

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Heparin and Normal Saline

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ethanol Lock and Normal Saline n=18 participants at risk All patients randomized to the ELT group will receive 3ml of 70% ethanol and saline flush.	Heparin and Normal Saline n=20 participants at risk All patients randomized to this group will receive Heparin lock (3 mL of 100 U/ml heparin) + saline infusion (current standard of care).
Infections and infestations Catheter-related bloodstream infection	22.2% 4/18 • Number of events 4 • 1 year	5.0% 1/20 • Number of events 1 • 1 year

Additional Information

Dr. Ryan Hurt

Mayo Clinic

Phone: 507-284-4461

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place