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

NCT02515201 | Unknown Phase 4

• 1 other identifier: 140291
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Catheter-Related Infections

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Study Arms (2)

Taurolidine

ACTIVE COMPARATOR

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

Heparin

ACTIVE COMPARATOR

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

Interventions

Taurolidine DRUG

taurolidine in central catheter lumen

Also known as: Taurolock

Taurolidine

Heparin DRUG

heparin in central venous catheter lumen

Also known as: heparin solution

Heparin

Eligibility Criteria

• Age: 30 Days - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

MeSH Terms

Conditions

Catheter-Related Infections

Interventions

taurolidine; Heparin

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• 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

  STUDY CHAIR

• Helena Goldani, PhD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Helena Goldani

Study Record Dates

• First Submitted: July 19, 2015
• First Posted: August 4, 2015
• Study Start: September 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: December 1, 2016
• Last Updated: August 4, 2015

Record last verified: 2015-07