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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-10-31

Brief Summary

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This study is being implemented to identify the role of prophylactic use of ethanol lock in adult patients on home parenteral nutrition (HPN). Central catheter related blood stream infection is a major complication in patients on HPN. The investigators hypothesize that the prophylactic use of ELT will decrease the number of catheter related blood stream infections compared to the control group. The investigators further hypothesize that with the introduction of prophylactic ELT, the number of infections will decrease.

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Detailed Description

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Catheter-related bloodstream infection (CRBSI) is a serious complication for home parenteral nutrition (HPN) patients causing morbidity, mortality, and prolonged hospitalization. CRBSIs may also result in the need for central venous catheter (CVC) removal and replacement. Current literature supports the use of antibiotics locks in patients with repeated CRBSI. There is a growing concern about the increased risk of microbial resistance with the long term use antibiotic locks. Ethanol lock therapy (ELT) has broad spectrum coverage and includes gram negative bacteria, gram positive bacteria, atypical bacteria, and fungi. Compared with antibiotic and other solution locks, which have limitations, ELT has excellent broad-spectrum bactericidal and fungicidal killing action and poses no problems with development of resistance over time. There is a lack of a randomized controlled study to characterize the role of ELT in adult patients on HPN.

Conditions

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Catheter-related Bloodstream Infection (CRBSI) Nos Bloodstream Infection Due to Central Venous Catheter Bloodstream Infection Due to Hickman Catheter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Ethanol Lock and Normal Saline

All patients randomized to the ELT group will receive 3ml of 70% ethanol and saline flush.

Group Type EXPERIMENTAL

Ethanol

Intervention Type DRUG

Prophylactic ELT will be administered at the time when the HPN is not being infused.

Normal Saline

Intervention Type DRUG

Heparin and Normal Saline

All patients randomized to this group will receive Heparin lock + saline infusion (current standard of care).

Group Type ACTIVE_COMPARATOR

Heparin Lock

Intervention Type DRUG

3 mL of 100 U/ml heparin

Normal Saline

Intervention Type DRUG

Interventions

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Ethanol

Prophylactic ELT will be administered at the time when the HPN is not being infused.

Intervention Type DRUG

Heparin Lock

3 mL of 100 U/ml heparin

Intervention Type DRUG

Normal Saline

Intervention Type DRUG

Other Intervention Names

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Alcohol lock Ethanol (EtOH) ELT therapy Hep-Lock Heparin N Saline 0.9 N saline

Eligibility Criteria

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Inclusion Criteria

* Newly started on Home parenteral Nutrition and anticipated duration \>3 months.
* Not previously on Home Parenteral Nutrition.
* Providing consent.
* Patients with non-medicare insurance.
* Patients with medicare insurance and a supplementary insurance.
* Patients with single lumen Hickman® catheters.
* No known alcohol addiction.

Exclusion Criteria

* Failure to provide consent
* Patients with medicare insurance and no other supplemental private insurance
* Patients with a catheter type other than a single lumen Hickman®
* Patients who are on HPN for less than three months
* Pregnant patients
* Patients who have previous proven addiction and dependence to alcohol.
* Patients lacking capacity to provide consent
* Patients who are not be managed by HPN team at investigator's institution

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No