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

This study has suspended participant recruitment.
(difficult recruiting)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01794767
First Posted: February 20, 2013
Last Update Posted: October 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Filippo Festini, University of Florence
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 Filippo Festini, 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 ]

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 ]
  • 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 ]

Estimated Enrollment: 52
Study Start Date: January 2013
Estimated Study Completion Date: August 2016
Primary Completion Date: August 2014 (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

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Ages Eligible for Study:   2 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01794767


Locations
Italy
Meyer Children Hospital
Florence, Tuscany, Italy, 50139
Sponsors and Collaborators
University of Florence
Investigators
Principal Investigator: Filippo Festini, RN, BSN, MSN University of Florence
  More Information

Responsible Party: Filippo Festini, Professor of Nursing, University of Florence
ClinicalTrials.gov Identifier: NCT01794767     History of Changes
Other Study ID Numbers: Heparin2012
First Submitted: January 29, 2013
First Posted: February 20, 2013
Last Update Posted: October 29, 2015
Last Verified: October 2015

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

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