Normal Saline Versus Heparinized Solution Flush for Maintaining Patency of Peripheral Venous Catheters in Children

Study Overview
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Brief Summary
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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.

Official Title
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Normal Saline Versus Heparinized Solution Flush for Maintaining Patency of Peripheral Venous Catheters in Children

Conditions
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Infection of Intravenous Catheter, Phlebitis, Extravasation of Diagnostic and Therapeutic Materials

Intervention / Treatment
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* Drug: 0,9% NaCl flush
* Drug: Heparin 50U/ml


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 0,9% NaCl flush<br>for children enrolled in this group, the nurse will perform the flushing of peripheral venous catheter using flush-solution as a bolus with saline 0.9% NaCl in the amount (ml) needed to fill the entire circuit of the catheter. The flushing will be performed routinely at the end of each fleboclisis | Drug: 0,9% NaCl flush<br>* Normal Saline solution<br>* Other names: Normal Saline;|
| Experimental: Heparin 50U/ml<br>for children enrolled in this group, the nurse will perform the washing of peripheral venous catheter using flush-solution as a bolus with heparin 50U/ml in the amount (ml) needed to fill the entire circuit of the catheter. The washing will be performed routinely at the end of each fleboclis | Drug: Heparin 50U/ml<br>* Heparin solution<br>* Other names: Heparin solution 50 U/ml, Epsodilave;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average length of stay on site of the catheter measured in hours |  | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of complications extimated overall and by type of complication |  | 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 | 
| Average cost for the maintenance of the catheter of each subject (pro day and in total) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripheral venous catheter, children.