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

NCT02227329 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2017-12-12

Study results available
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Summary

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.

Conditions

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

Interventions

DRUG

Ethanol

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

DRUG

Heparin Lock

3 mL of 100 U/ml heparin

DRUG

Normal Saline

Sponsors & Collaborators

Principal Investigators

  • Ryan Hurt, MD, PhD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02227329 on ClinicalTrials.gov