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

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

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.

Study Overview

• Status: Unknown
• Conditions: Catheter-Related Infections
• Intervention / Treatment: Drug: Taurolidine; Drug: Heparin

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: July 19, 2015
• First Submitted That Met QC Criteria: July 31, 2015
• First Posted (Estimate): August 4, 2015

Study Record Updates

• Last Update Posted (Estimate): August 4, 2015
• Last Update Submitted That Met QC Criteria: July 31, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Sepsis; Infections; Communicable Diseases; Catheter-Related Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Antineoplastic Agents; Anticoagulants; Heparin; Calcium heparin; Taurolidine
• Other Study ID Numbers: 140291