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

Primary Purpose

Catheter-Related Infections

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Taurolidine

Heparin

About this trial

This is an interventional prevention trial for Catheter-Related Infections

Eligibility Criteria

30 Days - 14 Years (Child)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Taurolidine

Heparin

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Bloodstream infection related to the use of central venous catheter

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02515201

First Posted

July 19, 2015

Last Updated

July 31, 2015

Sponsor

Hospital de Clinicas de Porto Alegre

1. Study Identification

Unique Protocol Identification Number

NCT02515201

Brief Title

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

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Unknown status

Study Start Date

September 2014 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Catheter-Related Infections

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Taurolidine

Arm Type

Active Comparator

Arm Description

Arm Title

Heparin

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Taurolidine

Other Intervention Name(s)

Taurolock

Intervention Description

taurolidine in central catheter lumen

Intervention Type

Drug

Intervention Name(s)

Heparin

Other Intervention Name(s)

heparin solution

Intervention Description

heparin in central venous catheter lumen

Primary Outcome Measure Information:

Title

Bloodstream infection related to the use of central venous catheter

Description

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.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Days

Maximum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: