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

University of Florence (UNIFI)

Status and phase: Suspended; Phase 4

Conditions: Extravasation of Diagnostic and Therapeutic Materials; Infection of Intravenous Catheter; Phlebitis

Treatments: Drug: Heparin 50U/ml; Drug: 0,9% NaCl flush

Study type: Interventional

Funder types: Other

Identifiers

NCT01794767

Heparin2012

Details and patient eligibility

About

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.

Enrollment: 52 estimated patients

Sex: All

Ages: 2 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

0,9% NaCl flush

Active Comparator group

Description:

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

Treatment:

Drug: 0,9% NaCl flush

Heparin 50U/ml

Experimental group

Description:

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

Treatment:

Drug: Heparin 50U/ml