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van CCT (UK)

van CCT (UK)

Ethanol Lock in Total parenteral nutrition Infections (ELTI study)

- candidate number3527
- NTR NumberNTR1356
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-jun-2008
- Secondary IDsAMC ELTI 
- Public TitleEthanol Lock in Total parenteral nutrition Infections (ELTI study)
- Scientific TitleAn explorative randomized placebo controlled open-label trial of ethanol lock therapy for the additional treatment of catheter-related bloodstream infections in parenteral nutrition patients with intravascular devices
- hypothesisEthanol lock therapy in TPN patients reduces the incidence of catheter-related infections and thrombosis.
- Healt Condition(s) or Problem(s) studiedThrombosis, Children, Catheter infections, Parenteral nutrition, Ethanol lock therapy, Adults
- Inclusion criteria1. TPN patients older than 3 months of age with a tunnelled central venous catheter with a clinical suspicion of a catheter related bloodstream infection
2. Patency of all lumina
3. Written informed consent
- Exclusion criteria1. Known alcohol allergy
2. Severe clinical sepsis or septic shock
3. Positive culture with a Staf. aureus or Candida species
4. Continuous fluid or TPN dependency
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2008
- planned closingdate1-sep-2010
- Target number of participants50
- InterventionsEthanol lock treatment. The instilled lock needs to dwell for a period of 3 -6 hours.
All CRIs will be treated with systemic antimicrobial therapy according to present local bacteriological protocols, being empiric broad spectrum at first and after knowing the susceptibility narrowing the antibiotics.
If this is not possible, the locks will be installed for as long as the patient can be treated without the use of the IVD in between the patientís TPN or other infusions. In cases of a double lumen IVD the study medication will be instilled in one lumen for 3 - 6 hours while the other lumen can be used for infusion. During the next 3 hours the other lumen will be locked with study medication, while the first lumen is being used for infusions. After the dwell period is completed, the ethanol-lock will be withdrawn, discarded and followed by a saline flush. This procedure will be repeated for as long as the patient is treated with antibiotics. In case of not being able to discard the study medication it will slowly be infused.
- Primary outcome1. 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- Duration of systemic antibiotic use
- Mortality
- Adverse reactions of ethanol- or placebo use
- Number of days of hospital admission.
- TimepointsFollow-up period of two years
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Amsterdam
- PublicationsN/A
- Brief summaryTo 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.
- Main changes (audit trail)
- RECORD25-jun-2008 - 25-jul-2008

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