Ethanol lock solution for the prevention of tunnelled central venous catheter infections in paediatric oncology patients
A randomized controlled trial

The use of indwelling central venous catheters has become commonplace in the
management of children undergoing anticancer treatment. However there are
disadvantages such as the risk of infections and the risk of thrombosis. The
risk of infection varies between 1.4-2.2 infections per 1000 catheter days.
Despite international guidelines on catheter insertion and handling, developed
by the Hospital Infection Control Practices committee, infections are still of
great importance.Most infections are caused by Gram-positive organisms(70%),
followed by Gram-negative organisms (15%) and fungal organisms (7%). The
standard prophylactic measure in inserted catheters in oncology children is
flushing with a heparin solution (100U/ml 3 mls) every time the catheter is
closed and not used for treatment such as chemotherapy and/or fluid or blood
products. No other prophylactic antibiotics are used. This is a routine measure
that is widely accepted. Even with these measures infections remain a problem.
Therefore newer flush solutions are being evaluated in preventing catheter
related infections not used during treatment for fever during neutropenia. An
antisepticum not used during neutropenic fever episodes would be preferable.
The ethanol lock solution is a promising method of decreasing catheter related
infections. Ethanol is a widely used antiseptic with no known acquired
resistance. It has been shown that ethanol locks disrupt the biofilm and is
lethal to the exposed organisms.
In a cohort study using ethanol lock in addition to systemic antibiotics in the
treatment of bloodstream infections in 28 children, 67% of patients had no
infectious relapse after ethanol lock within 4 weeks of treatment, compared
with 47% treated with systemic antibiotics alone.No side-effects were observed
from the ethanol-lock. Few case-reports have been reported using ethanol-lock
preventively with succes. It was shown that 2 hours of exposure to 70% ethanol
is required to kill established biofilms of Gram-positive bacteria,
Gram-negative bacteria and candida.

To prove the efficacy and safety of ethanol lock solution in preventing
catheter-related infections and subsequently venous thrombosis in children with
a malignant disease who will have a tunnelled central venous catheter inserted.

Multi-centered randomized double blind study

Central randomisation will be performed, allocating the patients to the control
or experimental group.
Both the patient and the investigators will be blinded to the treatment.
The lock solution in the experimental group will consist of 3 ml of 70%
ethanol. A volume of 3 ml of ethanol will be used to fill each catheter and
will be locked in place for 2 hours. This will be repeated once weekly.
Group B (control group): The lock solution will consist of 100U/ml Heparin, the
same procedure will be followed where 3 mls is locked into the catheter for 2
hours.
After the two hours the solution will be flushed with normal saline.

The extra burden for the patient are the 2 hours the patient has to wait during
the placement of the lock, before the catheter can be flushed with normal
saline. During the fist phase of therapy the patient will be hospitalized
frequently for chemotherapy, bloodtransfusions etc. We will plan the lock in a
way that the patient has to be here anyway. the patient does not have to come
to the hospital only to place the lock. It will be combined with chemotherapy
or out-patient visits.
Once a catheter related infection is suspected a sonar of the jugular and
subclavian vein will be done to exclude venous catheter thrombosis. At that
stage the patient will be hospitalized anyway to treat the infection with iv
antibiotics. During this admission the sonar will be done which will have a
duration of 15 minutes, it is not painful and not a burden for the patient.