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

Phlebitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01794767
• Other study ID #: Heparin2012
• Status: Suspended
• Phase: Phase 4
• First received: January 29, 2013
• Last updated: October 28, 2015
• Start date: January 2013
• Est. completion date: August 2016

Study information

• Verified date: October 2015
• Source: University of Florence
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 52
• Est. completion date: August 2016
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 14 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

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

Intervention

Drug:
• 0,9% NaCl flush
Normal Saline solution
• Heparin 50U/ml
Heparin solution

Locations

Country	Name	City	State
Italy	Meyer Children Hospital	Florence	Tuscany

Sponsors (1)

Lead Sponsor	Collaborator
University of Florence

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No