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

NCT ID: NCT01794767

Last Updated: 2015-10-29

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE4
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2016-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

0,9% NaCl flush

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

Group Type: ACTIVE_COMPARATOR

0,9% NaCl flush

Intervention Type: DRUG

Normal Saline solution

Heparin 50U/ml

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

Group Type: EXPERIMENTAL

Heparin 50U/ml

Intervention Type: DRUG

Heparin solution

Interventions

0,9% NaCl flush

Normal Saline solution

Intervention Type: DRUG

Heparin 50U/ml

Heparin solution

Intervention Type: DRUG

Other Intervention Names

Normal Saline; Heparin solution 50 U/ml, Epsodilave

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florence

OTHER

Sponsor Role: lead

Responsible Party

Filippo Festini

Professor of Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Filippo Festini, RN, BSN, MSN

Role: PRINCIPAL_INVESTIGATOR

University of Florence

Locations

Meyer Children Hospital

Florence, Tuscany, Italy

Countries

Italy

Other Identifiers

Heparin2012

Identifier Type: -

Identifier Source: org_study_id