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

Phase 4

Suspended

• Conditions: Phlebitis; Infection of Intravenous Catheter; Extravasation of Diagnostic and Therapeutic Materials
• Interventions: Drug: Heparin 50U/ml; Drug: 0,9% NaCl flush

• Registration Number: NCT01794767
• Lead Sponsor: University of Florence

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-29
• Study First Submitted QC: 2013-02-15
• Study First Posted: 2013-02-20
• Primary Completion: 2014-08
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-28
• Last Update Posted: 2015-10-29
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Heparin 50U/ml	Heparin 50U/ml	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
0,9% NaCl flush	0,9% NaCl flush	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Meyer Children Hospital; 🇮🇹 Florence, Tuscany, Italy