Ethanol lock therapy in TPN patients reduces the incidence of catheter-related infections and thrombosis.
ID
Bron
Verkorte titel
Aandoening
children, adults, TPN patients, ethanol lock therapy, catheter-related infection and catheter-related thrombosis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Persistent bacteremia >72 hours after start of ethanol/placebo lock OR<br>
2. Recurrence of bacteremia (with the same or other micro-organism) within 24 weeks OR<br>
3. Removal of the CVC OR<br>
4. Occurence of symptomatic venous thrombosis
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Ethanol lock therapy in TPN patients reduces the incidence of catheter-related infections and thrombosis.
Onderzoeksopzet
Follow-up period of two years
Onderzoeksproduct en/of interventie
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 After the dwell period is completed, the ethanol-lock will be withdrawn, discarded and followed by a saline flush.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.
Algemeen / deelnemers
Emma Children’s Hospital
Department of Pediatric Infectious Diseases
D. Pajkrt
Amsterdam
The Netherlands
+31 (0)20 5662727
D.Pajkrt@amc.uva.nl
Wetenschappers
Emma Children’s Hospital
Department of Pediatric Infectious Diseases
D. Pajkrt
Amsterdam
The Netherlands
+31 (0)20 5662727
D.Pajkrt@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL1307 |
NTR-old | NTR1356 |
Ander register | : AMC ELTI |
ISRCTN | ISRCTN wordt niet meer aangevraagd |