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

Sponsor

Hospital de Clinicas de Porto Alegre (Other)

Overall Status

Unknown status

CT.gov ID

NCT02515201

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Catheter-Related Infections	Drug: Taurolidine Drug: Heparin	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Mar 1, 2015

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Taurolidine taurolidine in central catheter lumen Other Names: 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.	Drug: Heparin heparin in central venous catheter lumen Other Names: heparin solution

Arm

Intervention/Treatment

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.

Drug: Taurolidine

taurolidine in central catheter lumen

Other Names:

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.

Drug: Heparin

heparin in central venous catheter lumen

Other Names:

heparin solution

Outcome Measures

Primary Outcome Measures

Bloodstream infection related to the use of central venous catheter [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Days to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hospital de Clinicas de Porto Alegre

Investigators

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