Heparin Versus Taurolidine to Bloodstream Infection Prevention Related in Central Venous Catheter in Children
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|ClinicalTrials.gov Identifier: NCT02515201|
Recruitment Status : Unknown
Verified July 2015 by Helena Ayako Sueno Goldani, Hospital de Clinicas de Porto Alegre.
Recruitment status was: Active, not recruiting
First Posted : August 4, 2015
Last Update Posted : August 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Catheter-Related Infections||Drug: Taurolidine Drug: Heparin||Phase 4|
Will be collected data about sociodemographics : date of birth, hospitalization and which is use (taurolidine or heparin), sex, underlying disease and associated co-morbidities.
About central venous catheter will be collect: catheter type in each period, the number of lumens, date of insertion of each catheter usage time, reason for removal of the catheter insertion site and catheter material (silicone or polyurethane ).
Data relating to parenteral nutrition will also be collected: osmolarity of parenteral nutrition, infusion time every 24 hours and concentration of glucose parenteral nutrition bag.
It will be used for aseptic handling technique of the solutions, as well as for handling the connections of the central catheter. For preparation and administration of taurolidine and heparin is used an operations manual that was made for the authors. Patients are divided into two groups: taurolidine or heparin.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Heparin Versus Taurolidine to Bloodstream Infection Prevention Related in Central Venous Catheter in Children With Intestinal Failure|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||March 2015|
|Estimated Study Completion Date :||December 2016|
Active Comparator: Taurolidine
Taurolidine be held in each infusion central venous catheter lumen with a volume that varies in accordance with the lumen via the catheter. The solution will be administered every day while the patient is on break from parenteral nutrition, and the catheter solution residence time will be the same time of the break from parenteral nutrition. Taurolidine infusion will be used TaurolockTM with ampoule presentation containing 3 ml.
taurolidine in central catheter lumen
Other Name: Taurolock
Active Comparator: Heparin
Heparin be held in each infusion central venous catheter lumen with a volume that varies in accordance with the lumen via the catheter. The solution will be administered every day while the patient is on break from parenteral nutrition, and the catheter solution residence time will be the same time of the break from parenteral nutrition. Heparin infusion will be used with heparin solution contain 50 International Unit (UI)/ml.
heparin in central venous catheter lumen
Other Name: heparin solution
- Bloodstream infection related to the use of central venous catheter [ Time Frame: 1 year ]Bloodstream infection related to the use of central venous catheter is defined as positive culture of microorganisms in blood samples collected from the central venous catheter.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02515201
|Study Chair:||Maria Carolina Witkowski, MD||Hospitall de Clínicas de Porto Alegre|
|Study Chair:||Adriano Taniguchi, MD||Hospital de Clínicas de Porto Alegre|
|Study Chair:||Elza Mello, PhD||Hospital de Clínicas de Porto Alegre|
|Study Chair:||Suzi Camey, PhD||Hospital de Clínicas de Porto Alegre|
|Principal Investigator:||Helena Goldani, PhD||Hospital de Clínicas de Porto Alegre|