70% Ethanol for Decontamination of CVL Exposed to Calcineurine Inhibitors Version 1.0, 1/9/2014
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any - 30 |
| Updated: | 4/21/2016 |
| Start Date: | May 2014 |
| End Date: | January 2016 |
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.
(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.
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients who are hemodynamically compromised or needing intensive care in the ICU.
- Family/patient not willing to sign an informed consent.
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