Suspended

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

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What is being tested

0,9% NaCl flush

+ Heparin 50U/ml

Drug
Who is being recruted

Cardiovascular Diseases+6

+ Pathologic Processes

+ Pathological Conditions, Signs and Symptoms

From 2 to 14 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Phase 4
Interventional
Study Start: January 2013
See protocol details

Summary

Principal SponsorUniversity of Florence
Last updated: October 29, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01794767
Principal SponsorUniversity of Florence
Last updated: October 29, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

52 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 2 to 14 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesVasculitisWounds and InjuriesPeripheral Vascular DiseasesExtravasation of Diagnostic and Therapeutic MaterialsPhlebitis

Criteria

8 inclusion criteria required to participate
Absence of diseases buoyancy coagulation (haemophilias and / or thrombophilias)
Age between 2 years and 14 years old
Medical prescription of intravenous antibiotic therapy for at least 2 doses on the day
No antecedents trombopenie dued to the use of any type of heparin or a pentosan polysulfate
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8 exclusion criteria prevent from participating
age outside the range 2 - 14 years
children for which the parents have not consented to the study
children for which there is no prescription of intravenous antibiotic therapy for at least 2 times a day
children in treatment with corticosteroids and / or anti-inflammatory
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
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

Group II

Experimental
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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Meyer Children Hospital

Florence, ItalyOpen Meyer Children Hospital in Google Maps
SuspendedOne Study Center