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

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

Status
Suspended
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01794767
Enrollment
52
Registered
2013-02-20
Start date
2013-01-31
Completion date
2016-08-31
Last updated
2015-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

peripheral venous catheter, children.

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.

Interventions

DRUG0,9% NaCl flush

Normal Saline solution

DRUGHeparin 50U/ml

Heparin solution

Sponsors

University of Florence
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
2 Years to 14 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Average length of stay on site of the catheter measured in hoursparticipants 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

MeasureTime frame
Incidence of complications extimated overall and by type of complicationparticipants 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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026