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

NCT02227329 | Terminated Phase 1 Results DMC

• 1 other identifier: 13-007793
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Home Parenteral Nutrition; Infection Prevention; CRBSI; Ethanol Lock Therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Ethanol Lock and Normal Saline

EXPERIMENTAL

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

Drug: Ethanol; Drug: Normal Saline

Heparin and Normal Saline

ACTIVE COMPARATOR

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

Drug: Heparin Lock; Drug: Normal Saline

Interventions

Ethanol DRUG

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

Also known as: Alcohol lock, Ethanol (EtOH), ELT therapy

Ethanol Lock and Normal Saline

Heparin Lock DRUG

3 mL of 100 U/ml heparin

Also known as: Hep-Lock, Heparin

Heparin and Normal Saline

Normal Saline DRUG

Also known as: N Saline, 0.9 N saline

Ethanol Lock and Normal Saline; Heparin and Normal Saline

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related 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. 2018 Aug;37(4):1181-1185. doi: 10.1016/j.clnu.2017.05.009. Epub 2017 May 17.

  PMID: 28576557 RESULT

MeSH Terms

Conditions

Pyloric Stenosis, Hypertrophic

Interventions

Ethanol; Vascular Access Devices; Heparin; Saline Solution

Condition Hierarchy (Ancestors)

Pyloric Stenosis; Gastric Outlet Obstruction; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Catheters; Equipment and Supplies; Glycosaminoglycans; Polysaccharides; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

Due to European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines on chronic intestinal failure in adults advising against ELT, we conducted an interim analysis. The study was terminated early; further study would not change outcome.

Results Point of Contact

• Title: Dr. Ryan Hurt
• Organization: Mayo Clinic

Hurt.Ryan@mayo.edu

507-284-4461

Study Officials

• Ryan Hurt, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: August 15, 2014
• First Posted: August 28, 2014
• Study Start: July 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: December 12, 2017
• Results First Posted: December 12, 2017

Record last verified: 2017-11

Locations

US (1)