70% Ethanol for Decontamination of CVL Exposed to Calcineurine Inhibitors Version 1.0, 1/9/2014

NCT02441075 | Completed

• 1 other identifier: 14-00028
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This is for a study for patients that will be undergoing hematopoietic stem cell transplant (HSCT). For HSCT, patients will need a double lumen central venous line (CVL). One of the most common complications after an HSCT is Graft Versus Host Disease (GVHD).Tacrolimus or Cyclosporine along with methotrexate are used together in order to prevent GVHD. Normally these medications are given via the white lumen and blood is drawn via the unexposed red lumen to check the blood level of these medications. If these drugs are accidentally given via the wrong lumen (line) it could cause blood levels to be falsely high. This error could lead to the patient having to have peripheral blood draws that cause pain. The investigators are proposing adding an ethanol lock to your lumens (lines) to see if this would help clean the lines therefore preventing errors in blood tests and blood draws. An ethanol lock is a 70% alcohol which is injected into the CVL lumen and stays within the CVL as the CVL is capped.

Conditions

Hematopoietic Stem Cell Transplant; GVHD

Keywords

patients; BMT; cyclosporine; tacrolimus; HSCT

Outcome Measures

Primary Outcomes (1)

• Primary Outcome: Serum Levels

  Serum levels from both lumens will be compared after 2-hour ethanol lock placements. If the mean serum levels drawn at 8pm from both lumens are equivalent, the intervention will be considered effective.

  18 months

Study Arms (1)

70% Ethanol

EXPERIMENTAL

The study will use 70% ethanol lock in the CVLs. A 2ml 70% ethanol lock will be instilled into the white lumen of the CVL for 2 hours. At the end of 2 hours, the ethanol will be withdrawn; the CVL lumen flushed with normal saline, and the CVL would be available for normal use for that day.

Other: 70% Ethanol

Interventions

70% Ethanol OTHER

the study will use 70% ethanol lock in the CVLs. A 2ml 70% ethanol lock will be instilled into the white lumen of the CVL for 2 hours. At the end of 2 hours, the ethanol will be withdrawn; the CVL lumen flushed with normal saline, and the CVL would be available for normal use for that day.

70% Ethanol

Eligibility Criteria

• Age: 3 Months - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All patients' ages 3 months to 30 years will be eligible for the study.
• All patients undergoing an allogeneic HSCT and receiving intravenous cyclosporine or tacrolimus through a CVL will be eligible.

You may not qualify if:

• Patients who are hemodynamically compromised or needing intensive care in the ICU.
• Family/patient not willing to sign an informed consent.

Sponsors & Collaborators

• Nationwide Children's Hospital: lead
• Daisy Foundation: collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Interventions

Ethanol

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: May 12, 2015
• Study Start: May 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 29, 2016

Record last verified: 2016-01

Locations

US (1)