No registrations found.
ID
Source
Brief title
Health condition
children, adults, TPN patients, ethanol lock therapy, catheter-related infection and catheter-related thrombosis
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
- Duration of systemic antibiotic use
- Mortality
- Adverse reactions of ethanol- or placebo use
- Number of days of hospital admission.
Background summary
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 objective
Ethanol lock therapy in TPN patients reduces the incidence of catheter-related infections and thrombosis.
Study design
Follow-up period of two years
Intervention
Ethanol 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 patient’s 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 After the dwell period is completed, the ethanol-lock will be withdrawn, discarded and followed by a saline flush.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.
Emma Children’s Hospital
Department of Pediatric Infectious Diseases
D. Pajkrt
Amsterdam
The Netherlands
+31 (0)20 5662727
D.Pajkrt@amc.uva.nl
Emma Children’s Hospital
Department of Pediatric Infectious Diseases
D. Pajkrt
Amsterdam
The Netherlands
+31 (0)20 5662727
D.Pajkrt@amc.uva.nl
Inclusion criteria
1. 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 criteria
1. 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
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 |
|---|---|
| NTR-new | NL1307 |
| NTR-old | NTR1356 |
| Other | : AMC ELTI |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |