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

Catheter-related Bloodstream Infection (CRBSI) Nos Clinical Trial

— ELT  

Official title:

Prophylactic Ethanol Lock Therapy (ELT) in Patients on Home Parenteral Nutrition: A Prospective Randomized Control Trial.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02227329
• Other study ID #: 13-007793
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: August 15, 2014
• Last updated: November 13, 2017
• Start date: July 2014
• Est. completion date: October 2016

Study information

• Verified date: November 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Ethanol
Prophylactic ELT will be administered at the time when the HPN is not being infused.
• Heparin Lock
3 mL of 100 U/ml heparin
• Normal Saline

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

Salonen BR, Bonnes SL, Vallumsetla N, Varayil JE, Mundi MS, Hurt RT. A prospective double blind randomized controlled study on the use of ethanol locks in HPN patients. Clin Nutr. 2017 May 17. pii: S0261-5614(17)30170-X. doi: 10.1016/j.clnu.2017.05.009. [ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Catheter-Related Blood Stream Infections	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.	1 year