|- candidate number||3198|
|- NTR Number||NTR1275|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-apr-2008|
|- Secondary IDs||Financing KIKAnumber 1561 AMR project code CC551002|
|- Public Title||The Aristocaths study|
|- Scientific Title||Ethanol lock solution for the prevention of tunnelled central venous catheter infections in paediatric oncology patients, a randomized controlled trial.|
|- Healt Condition(s) or Problem(s) studied||Central vein catheter , Catheter infections, Paediatric oncology patients, Ethanol|
|- Inclusion criteria||Paediatric oncology patients between 1 and 18 years of age with a newly inserted tunnelled central venous catheter (both internal and external devices) will be eligible for the study.|
|- Exclusion criteria||1. Children who have a documented infection at the time of catheter insertion |
2. Children <1 year at diagnosis
3. Children with an existing primary immunological disorder
4. Placement of the central venous catheter in the site of a previously radiographically confirmed venous thrombosis
5. Allergy for ethanol
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2007|
|- planned closingdate||1-okt-2010|
|- Target number of participants||600|
|- Interventions||Central randomisation will be performed, allocating the patients to the control or experimental group. Both the patient and the investigators will be blinded tot the treatment. |
The experimental group: Ethanol 70%-ARM
For patients who are randomized to the ethanol 70% arm, the lock solution will consist of 3 ml of 70% ethanol. A volume of 3 ml of ethanol will be used to fill the catheter and will be locked in place for 2 hours. If the child receives a baby port the the lock solution will only be 1.5 mls for 2 hours. This will be repeated once weekly (range 5-10 days). If the child has a port a cath and does not need treatment within one week then it is allowed to extend the lock procedure. If the child has a double lumen Broviac inserted the lock solution per catheter will be 1.5 mls. After 2 hours the lock solution will be flushed with 3 ml of normal saline and 3 mls standard heparin will be used to close the catheter.. If the catheter needs to be used in between, the standard procedure will be followed: flushing the catheter with 3 ml of heparin
The control group: Heparin 100 U/ml- ARM
For patients who are randomized to the standard heparin 100 U/ml-arm, the lock solution will consist of 3 ml of heparin 100 U/ml. A volume of 3 ml will be used to fill each catheter and will be locked in place for 2 hours. If the child receives a baby port the lock solution will only be 1.5 mls for 2 hours. This will be repeated once weekly (range 5-10 days). If the child has a port a cath and does not need treatment within one week then it is allowed to extend the lock procedure. If the child has a double lumen Broviac inserted the lock solution per catheter will be 1.5 mls. After 2 hours the lock solution will be flushed with 3 ml of normal saline and 3 mls standard heparin will be used to close the catheter. If the catheter needs to be used in between, the standard procedure will be followed: flushing the catheter with 3 ml of heparin 100U/ml.
|- Primary outcome||First endpoint: |
All patients will be prospectively followed till time of first documented catheter related infection, till death, or till removal of the catheter, whatever endpoint will come first. Maximum duration of the study 6 months.
Occurence of fever (with or without neutropenia), occurence of thrombosis (clinical or subclinical days of hospital admission, clinical sverity of the infection, outcome.
|- Secondary outcome||Side effects will be registered, focussing on allergic reactions, “flushing” of the face, dizziness, warm feeling and liver (ASAT, ALAT) These reactions will be registered in the first hour after flushing the lock.|
|- Timepoints||Interim analyses: 1,5 year after start study!|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||PhD. K.M. Pal, van der-de Bruin|
|- CONTACT for SCIENTIFIC QUERIES||Dr. M.D. Wetering|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Dutch Childhood Oncology Group, The Hague|
|- Brief summary||Background|
The use of tunnelled central venous catheters has many advantages in the treatment of children with cancer. However, especially in children with long neutropenic episodes, the risk of infection and subsequently venous thrombosis is present, which can lead to severe morbidity.
Objective of the study
To evaluate the efficacy and safety of ethanol lock solution for prevention of catheter-related infections in children treated for cancer compared to standard heparin solution.
Multicentre randomised controlled trial in paediatric oncology patients ages 1-18 years in whom a tunnelled central venous catheter will be inserted.
Intervention: After insertion of the catheter an ethanol (70%)-lock solution will be administered (3 mls) for a duration of 2 hours, once weekly or longer if the catheter is not locked in between. The control-group will be locked with the standard heparin (100U/ml) solution (3 mls).
The primary outcome measure will be the first catheter-related bacteraemia, death of the patient, or removal of the catheter, whatever comes first. As secondary outcome measures fever, antibiotic use, days of hospital admission and the presence of thrombosis will be evaluated. For each patient, the maximim duration of the study will be 6 months.
Poweranalysis: To reduce the catheter related infection rate from 30% to 15%, 300 tunnelled catheters are needed in both arms with 85% of detecting a difference.
If ethanol lock solution will decrease the number of infections and thrombosis, this will lead to a reduction in morbidity and mortality due to infections, and less postponement of chemotherapeutic treatment with ultimate higher survival. Ethanol lock solutions will be used routinely in all pediatric cancer centres in the Netherlands and possibly international.
|- Main changes (audit trail)|
|- RECORD||14-apr-2008 - 21-apr-2008|