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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Florence
Sponsor:
Information provided by (Responsible Party):
Filippo Festini, University of Florence
ClinicalTrials.gov Identifier:
NCT01794767
First received: January 29, 2013
Last updated: February 15, 2013
Last verified: February 2013
  Purpose

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.

Condition Intervention Phase
Infection of Intravenous Catheter
Phlebitis
Extravasation of Diagnostic and Therapeutic Materials
Drug: 0,9% NaCl flush
Drug: Heparin 50U/ml
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Normal Saline Versus Heparinized Solution Flush for Maintaining Patency of Peripheral Venous Catheters in Children

Resource links provided by NLM:


Further study details as provided by University of Florence:

Primary Outcome Measures:
  • Average length of stay on site of the catheter measured in hours [ Time Frame: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of complications extimated overall and by type of complication [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Average cost for the maintenance of the catheter of each subject (pro day and in total) [ Time Frame: 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 52
Study Start Date: January 2013
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
Drug: 0,9% NaCl flush
Normal Saline solution
Other Name: Normal Saline
Experimental: 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
Drug: Heparin 50U/ml
Heparin solution
Other Name: Heparin solution 50 U/ml, Epsodilave

  Eligibility

Ages Eligible for Study:   2 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01794767

Contacts
Contact: Filippo Festini, RN, BSN, MSN +393472108993 filippo.festini@unifi.it

Locations
Italy
Meyer Children Hospital Recruiting
Florence, Tuscany, Italy, 50139
Contact: Daniele Ciofi, RN, MSN    +390555662417    d.ciofi@meyer.it   
Sponsors and Collaborators
University of Florence
Investigators
Principal Investigator: Filippo Festini, RN, BSN, MSN University of Florence
  More Information

No publications provided

Responsible Party: Filippo Festini, Professor of Nursing, University of Florence
ClinicalTrials.gov Identifier: NCT01794767     History of Changes
Other Study ID Numbers: Heparin2012
Study First Received: January 29, 2013
Last Updated: February 15, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University of Florence:
peripheral venous catheter, children.

Additional relevant MeSH terms:
Phlebitis
Extravasation of Diagnostic and Therapeutic Materials
Pathologic Processes
Wounds and Injuries
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Vasculitis
Calcium heparin
Heparin
Pharmaceutical Solutions
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 14, 2014