- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02515201
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
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.
|
taurolidine in central catheter lumen
Other Names:
|
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.
|
heparin in central venous catheter lumen
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Collaborators and Investigators
Investigators
- Study Chair: Maria Carolina Witkowski, MD, Hospitall de Clínicas de Porto Alegre
- Study Chair: Adriano Taniguchi, MD, Hospital de Clinicas de Porto Alegre
- Study Chair: Elza Mello, PhD, Hospital de Clinicas de Porto Alegre
- Study Chair: Suzi Camey, PhD, Hospital de Clinicas de Porto Alegre
- Principal Investigator: Helena Goldani, PhD, Hospital de Clinicas de Porto Alegre
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Catheter-Related Infections
-
Leonard-Meron Biosciences, Inc.RecruitingCatheter-related InfectionsUnited States, Puerto Rico
-
University of OklahomaTerminatedCatheter Related InfectionsUnited States
-
Aalborg University HospitalUnknownCatheter-Related Infections | Catheter Related ComplicationDenmark
-
Catholic University of PelotasCompletedCatheter Related Infection
-
Universitaire Ziekenhuizen KU LeuvenUnknown
-
Hospital Nossa Senhora da ConceicaoUnknownCatheter Related InfectionBrazil
-
Catholic University of the Sacred HeartISS, Dip.Tecnologie e Salute, Prof. Gianfranco DonelliCompletedCentral Venous Catheter Related InfectionsItaly
-
Poitiers University HospitalCompletedPreventing Catheter Related InfectionFrance
-
University Hospital, AngersNot yet recruitingCatheter Infection | Catheter-Related Infections | Catheter Complications | Catheter Related Complication | Catheter-related Bloodstream Infection
-
Hôpital Raymond PoincaréUnknownCatheter Related Infection | Infection of Catheter Exit SiteFrance
Clinical Trials on Taurolidine
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)CompletedBrain and Central Nervous System TumorsUnited States
-
Stanley Dudrick's Memorial HospitalCompletedCentral Venous Catheter | Home Parenteral NutritionPoland
-
Geert WantenGeistlich Pharma AGCompletedCatheter Related Blood Stream InfectionsUnited Kingdom, Israel, Denmark, Germany, Italy, Netherlands
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)CompletedOvarian Cancer | Fallopian Tube Cancer | Primary Peritoneal Cavity CancerUnited States
-
Radboud University Medical CenterCompletedSepsis | Infection | Parenteral NutritionNetherlands
-
Centre Hospitalier Régional Metz-ThionvilleTheradial; centre régional de pharmacovigilance de NancyCompletedCatheter-Related InfectionsFrance
-
Universitair Ziekenhuis BrusselCompletedInfection | PatencyBelgium
-
University Hospital, RouenTerminated
-
Imperial College Healthcare NHS TrustCompletedCatheter-Related Infections | Renal DialysisUnited Kingdom
-
Geistlich Pharma AGCompletedPeriodontitisUnited States