Clinical trial NCT02515201: Heparin Versus Taurolidine to Bloodstream Infection Prevention Related in Central Venous Catheter in Children
Official title: Heparin Versus Taurolidine to Bloodstream Infection Prevention Related in Central Venous Catheter in Children With Intestinal Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Catheter-Related Infections
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2015-08-04
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bloodstream infection related to the use of central venous catheter
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospitall de Clínicas de Porto Alegre
name: Maria Carolina Witkowski, MD
role: STUDY_CHAIR
affiliation: Hospital de Clínicas de Porto Alegre
name: Adriano Taniguchi, MD
role: STUDY_CHAIR
affiliation: Hospital de Clínicas de Porto Alegre
name: Elza Mello, PhD
role: STUDY_CHAIR
affiliation: Hospital de Clínicas de Porto Alegre
name: Suzi Camey, PhD
role: STUDY_CHAIR
affiliation: Hospital de Clínicas de Porto Alegre
name: Helena Goldani, PhD
role: PRINCIPAL_INVESTIGATOR
References: