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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Tuscany
    • Florence, Tuscany, Italy, 50139
      • Meyer Children Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: 0,9% NaCl flush; Normal Saline solution; Other Names: Normal Saline
Experimental: 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	Drug: Heparin 50U/ml; Heparin solution; Other Names: Heparin solution 50 U/ml, Epsodilave

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Florence
• Investigators: Principal Investigator: Filippo Festini, RN, BSN, MSN, University of Florence

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: January 29, 2013
• First Submitted That Met QC Criteria: February 15, 2013
• First Posted (Estimate): February 20, 2013

Study Record Updates

• Last Update Posted (Estimate): October 29, 2015
• Last Update Submitted That Met QC Criteria: October 28, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: peripheral venous catheter, children.
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Wounds and Injuries; Vasculitis; Peripheral Vascular Diseases; Phlebitis; Extravasation of Diagnostic and Therapeutic Materials; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Calcium heparin
• Other Study ID Numbers: Heparin2012