Clinical trial NCT01794767: Normal Saline Versus Heparinized Solution Flush for Maintaining Patency of Peripheral Venous Catheters in Children
Official title: Normal Saline Versus Heparinized Solution Flush for Maintaining Patency of Peripheral Venous Catheters in Children
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE4
Conditions: Infection of Intravenous Catheter
Phlebitis
Extravasation of Diagnostic and Therapeutic Materials
Keywords: peripheral venous catheter, children.
Lead sponsor: University of Florence
Sponsor class: OTHER
First posted: 2013-02-20
Enrollment: 52
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to verify if the periodic flush with normal saline 0.9% NaCl causes a longer or equal duration of patency of peripheral venous catheters, compared with heparin solution 50 U / ml flush, in children from 2 years to 14 years. Only 22 and 24 gauge catheters Will be included in the study.The study will assess in particular:

* the difference of permanence in situ of the device
* the difference in incidence of complications (in detail: obstruction, phlebitis, thrombocytopenia, systemic anticoagulation)
* the difference in costs between use of saline normal saline 0.9% NaCl solution and heparinized 50 U / ml.


Eligibility criteria: Inclusion Criteria:

* Age between 2 years and 14 years old
* Medical prescription of intravenous antibiotic therapy for at least 2 doses on the day
* Presence of informed consent to participate to the study provided by the parents
* No known hypersensitivity to heparin
* No known hypersensitivity to the patch fixing materials (polyurethane and / or glue)
* Absence of diseases buoyancy coagulation (haemophilias and / or thrombophilias)
* No antecedents trombopenie dued to the use of any type of heparin or a pentosan polysulfate
* No existing treatment based on corticosteroids and / or anti-inflammatory

Exclusion Criteria:

* age outside the range 2 - 14 years
* children for which there is no prescription of intravenous antibiotic therapy for at least 2 times a day
* children for which the parents have not consented to the study
* children with known hypersensitivity to heparin
* children with known hypersensitivity to the patch fixing materials (polyurethane and / or adhesive)
* children with disease-causing buoyancy coagulation (Hemophilia and / or thrombophilia)
* children with antecedents of trombopenie occurring by the use of any type of heparin or of a pentosan polyphosphate
* children in treatment with corticosteroids and / or anti-inflammatory

Primary outcomes:
measure: Average length of stay on site of the catheter measured in hours
timeFrame: participants will be followed for the duration on site of the first peripheral venous catheter inserted to each recruited subject, i.e. for an expected average of 10 dayse
Secondary outcomes:
measure: Incidence of complications extimated overall and by type of complication
timeFrame: participants will be followed for the duration on site of the first peripheral venous catheter inserted to each recruited subject, i.e. for an expected average of 10 days
measure: Average cost for the maintenance of the catheter of each subject (pro day and in total)
timeFrame: participants will be followed for the duration on site of the first peripheral venous catheter inserted to each recruited subject, i.e. for an expected average of 10 days
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Meyer Children Hospital
state: Tuscany
Study officials:
affiliation: University of Florence
name: Filippo Festini, RN, BSN, MSN
role: PRINCIPAL_INVESTIGATOR
References: