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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
Sponsor:
Information provided by (Responsible Party):
Helena Ayako Sueno Goldani, Hospital de Clinicas de Porto Alegre

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2014
Actual Primary Completion Date : March 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

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 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.
Drug: Heparin
heparin in central venous catheter lumen
Other Name: heparin solution




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   up to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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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
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Responsible Party: Helena Ayako Sueno Goldani, Helena Goldani, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02515201    
Other Study ID Numbers: 140291
First Posted: August 4, 2015    Key Record Dates
Last Update Posted: August 4, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Catheter-Related Infections
Taurolidine
Heparin
Calcium heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents
Anti-Infective Agents, Local
Antineoplastic Agents