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Heparin Versus Taurolidine to Bloodstream Infection Prevention Related in Central Venous Catheter in Children

Heparin Versus Taurolidine to Bloodstream Infection Prevention Related in Central Venous Catheter in Children With Intestinal Failure

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02515201
Enrollment
20
Registered
2015-08-04
Start date
2014-09-30
Completion date
2016-12-31
Last updated
2015-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter-Related Infections

Brief summary

Clinical trial, that aim is evaluation of the use of taurolidine and heparin in the prevention of bloodstream infection in venous catheter in children with intestinal failure.

Detailed description

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.

Interventions

taurolidine in central catheter lumen

DRUGHeparin

heparin in central venous catheter lumen

Sponsors

Hospital de Clinicas de Porto Alegre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Days to 14 Years
Healthy volunteers
No

Inclusion criteria

* The population will consist of patients 30 days of life to fourteen years old, admitted to the pediatric inpatient units, with intestinal failure receiving parenteral nutrition through a central venous catheter and at least eight weeks of use forecast.

Exclusion criteria

* Children will be excluded other associated diseases that occur with frequent use of antibiotics, for example, cystic fibrosis, primary or acquired immunodeficiency. Also excluded are the children admitted that they are not accompanied by a responsible family recognition, or accompanied by responsible under the age of 18 years. Children with allergic reactions to the use of some of the solutions (taurolidine or heparin) will be suspended medication and receive appropriate treatment. Although these children have stopped the use of medication, will be followed according to the assessment protocol by the end of the study.

Design outcomes

Primary

MeasureTime frameDescription
Bloodstream infection related to the use of central venous catheter1 yearBloodstream 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026