To study the effect of ethanol lock therapy on the cure rate of catheter-related infections (CRIs) and on the incidence of (CRI related) venous thrombosis in pediatric total parenteral nutrition (TPN) patients with tunneled central venous catheters…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Treatment failure is defined as occurence of 1 of the following endpoints
within
24 weeks after start of ethanol/heparin therapy:
1. Persistent bacteremia >72 hours after start of ethanol/heparin lock OR
2. Recurrence of bacteremia (with the same or other micro-organism) within 24
weeks OR
3. Removal of the CVC OR
4. Occurence of symptomatic venous thrombosis
Secondary outcome
Secondary endpoints:
Duration of systemic antibiotic use, mortality, adverse reactions of ethanol-
or
heparin use, number of days of hospital admission.
Background summary
Pediatric patients receiving total parenteral nutrition (TPN). These patients
depend on
the maintenance of venous access for survival. A high rate of catheter-related
infections up to 8.3 per 1000 catheter days has been reported in TPN patients.
In order to reduce the incidence of the CRIs and the numbers of CRI related
catheter removals, new methods of prophylaxis and treatment have been evaluated
in recent years.
These include antibiotic-lock therapy with or without
thrombolytic/anticoagulant
agents. Recently two retrospective studies reported the positive effect of
ethanol lock therapy in pediatric oncology patients on the incidence of
(recurrent or persistent) CRI. Up to date there are no prospective data
available of ethanol lock therapy for the treatment of CRI in TPN patients.
Beside an increased risk for CRIs in long-term TPN patients, central venous
thrombosis is a frequent complication described in these patients. A causative
relation between catheter-related venous thrombosis and CRI has been described
in pediatric oncology patients. A prospective study is needed to evaluate the
incidence of central venous thrombosis in relation with the occurrence of a CRI
in pediatric TPN patients.
The aim of this randomised study is to evaluate the effect of ethanol lock
therapy on the incidence of CRIs and (CRIs related venous thrombosis) in
pediatric TPN
patients in combination with the standard antimicrobial treatment.
Study objective
To study the effect of ethanol lock therapy on the cure rate of
catheter-related infections (CRIs) and on the incidence of (CRI related) venous
thrombosis in pediatric total parenteral nutrition (TPN) patients with tunneled
central venous catheters older than 3 months of age.
Study design
A randomised open-label trial to evaluate the effect of ethanol lock therapy on
top of standard care of antimicrobial therapy of catheter-related bloodstream
infections and (CRI related) venous thrombosis in pediatric total parenteral
nutrition patients with intravascular devices.
Study burden and risks
In this study, the ethanol is not flushed through the catheter and therefore
the
risk of systemic ethanol levels is neglectable. However it may occur that it is
not possible to withdraw the ethanol solution and that it has to be flushed. In
these cases symptoms may occur and consist of transient light-headedness.
After inclusion of 420 adult patients in an ongoing placebo controlled study on
the use of ethanol lock 70% at Erasmus MC in Rotterdam no serious drug-related
adverse events were observed. The extent of this burden does not weight out the
potential benefit of participation, meaning a reduction in incidence of CRIs,
hospital admissions and catheter removals and prolonged catheter
meibergdreef 5
1105 AZ Amsterdam
NL
meibergdreef 5
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
*Pediatric total parenteral nutrition patients older than 3
months of age with a tunnelled central venous catheter (see definition
below) with a (clinical) suspicion of a Catheter Related bloodstream
Infection (CRI) in which according to the treating physician antimicrobial
therapy is indicated. All CRIs will simultaneously be treated with
systemic antimicrobial agents according to present local guideline.
* patency of all lumina prior to initiation of ethanol locks
* written informed consent
Exclusion criteria
* known alcohol allergy
* severe clinical sepsis or septic shock, defined as the need for
vaso-active drugs or mechanical respiratory support
* a positive blood culture with a Staphylococcus aureus or Candida
species, (the catheter has to be removed in these cases)
* continuous fluid or TPN dependency
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL26618.018.09 |