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

NCT01794767 | Suspended Phase 4

• 1 other identifier: Heparin2012
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

peripheral venous catheter, children.

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

• 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

Study Arms (2)

0,9% NaCl flush

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

Drug: 0,9% NaCl flush

Heparin 50U/ml

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

Drug: Heparin 50U/ml

Interventions

0,9% NaCl flush DRUG

Normal Saline solution

Also known as: Normal Saline

0,9% NaCl flush

Heparin 50U/ml DRUG

Heparin solution

Also known as: Heparin solution 50 U/ml, Epsodilave

Heparin 50U/ml

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florence: lead

Study Sites (1)

Meyer Children Hospital

Florence, Tuscany, 50139, Italy

Location

MeSH Terms

Conditions

Phlebitis; Extravasation of Diagnostic and Therapeutic Materials

Interventions

Saline Solution; Heparin

Condition Hierarchy (Ancestors)

Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Vasculitis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Filippo Festini, RN, BSN, MSN

  University of Florence

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nursing

Study Record Dates

• First Submitted: January 29, 2013
• First Posted: February 20, 2013
• Study Start: January 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2016
• Last Updated: October 29, 2015

Record last verified: 2015-10

Locations

IT (1)