70% Ethanol for Decontamination of CVL Exposed to Calcineurine Inhibitors Version 1.0, 1/9/2014
Condition: Hematopoietic Stem Cell Transplant; GVHD
Study type: Interventional

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.
    

Detailed description: 
      As cyclosporine and tacrolimus are both oil based medications and ethanol (70% alcohol) can
      dissolve oil, the investigators hypothesize that an alcohol lock instilled into the lumen of
      the CVL will be able to dissolve and leach out the oil based CNI adhering to the inside lumen
      of the CVL catheter, thus decontaminating it. The safety of using ethanol via CVL is already
      proven over the last many years. A study performed with neonates resulted in no adverse
      effects when using ethanol locks, proving that their use is safe for the pediatric
      population. Ethanol has been used as locks for disinfecting CVLs infected with a broad range
      of microorganisms in pediatrics. It has also been useful in treating catheter occlusions
      caused by Lipid formation. By placing a 70% ethanol lock for two hours in the contaminated
      lumen, it has shown to degrade the biofilm and fat formation allowing for further use of the
      CVL used 70 % ethanol locks and did not find any reductions in mechanical integrity of
      polyetherurethane or silicone catheters exposed for as long as 10 weeks. Also, no structural
      integrity complications have been found in the literature along with no evidence of systemic
      toxicity with the use of ethanol locks. A retrospective study on PICU patients who had
      received ethanol locks for 12-24 hours per lumen and a repeat lock when venous access was not
      limited, flushed 0.2-1mls of ethanol through the catheter at the end of the dwell instead of
      withdrawing the lock. Sixteen patients who received five daily ethanol lock treatments in
      succession, had liver enzymes measured and only two patients had mildly elevated
      transaminases, but these levels were not significant from their baseline levels. There were
      also no reports from the nurses of any patient complaints or side effects. The study stated
      that when larger volumes in which they classified as 2.3mls of ethanol are flushed through
      the central line, patients have reported flushing, light-headedness, headache, nausea and
      dyspnea. Only 2mls of ethanol will be administered in this study, and the ethanol lock will
      be withdrawn prior to drawing the levels. Therefore, no side effects are expected.
    

Intervention name(s): 70% Ethanol
Intervention type(s): Other
Intervention description(s): 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.
Intervention MeSH terms: Ethanol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: patients; BMT; cyclosporine; tacrolimus; HSCT