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Infection of Intravenous Catheter | Normal Saline Versus Heparinized Solution Flush for Maintaining Patency of Peripheral Venous Catheters in Children

Infection of Intravenous Catheter research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Infection of Intravenous Catheter

Phlebitis

Extravasation of Diagnostic and Therapeutic Materials

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:0,9% NaCl flushNormal Saline solution

Drug:Heparin 50U/mlHeparin solution

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

0,9% NaCl flushfor 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

Heparin 50U/mlfor 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 Status

Suspended

Start Date: January 2013

Completed Date: August 2016

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Average length of stay on site of the catheter measured in hours

Secondary Outcome: Incidence of complications extimated overall and by type of complication

Study sponsors, principal investigator, and references

Principal Investigator: Filippo Festini, RN, BSN, MSN

Lead Sponsor: University of Florence

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01794767

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