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 total parenteral nutrition (TPN) patients with tunneled central venous catheters older than…
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/placebo therapy:
1. Persistent bacteremia >72 hours after start of ethanol/placebo 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 placebo use, number of days of hospital admission.
Background summary
Catheter-related bloodstream infection (CRI) is an important complication in
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 TPN patients.
The aim of this randomised placebo-controlled study is to evaluate the effect
of ethanol lock therapy on the incidence of CRIs and (CRIs related venous
thrombosis) in TPN patients older than 3 months of age 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 total parenteral nutrition (TPN) patients with tunneled central
venous catheters older than 3 months of age.
Study design
A randomised placebo-controlled 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
total parenteral nutrition patients with intravascular devices.
Intervention
Ethanol lock therapy versus placebo lock therapy.
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 survival time
meibergdreef 9
1105 AZ Amsterdam
NL
meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
* 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
Medical products/devices used
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 | NL24035.018.08 |
| Other | nog niet bekend, volgt |