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

Primary Purpose

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

Status
Suspended
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
0,9% NaCl flush
Heparin 50U/ml
Sponsored by
University of Florence
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infection of Intravenous Catheter focused on measuring peripheral venous catheter, children.

Eligibility Criteria

2 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Meyer Children Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

0,9% NaCl flush

Heparin 50U/ml

Arm Description

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

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

Outcomes

Primary Outcome Measures

Average length of stay on site of the catheter measured in hours

Secondary Outcome Measures

Incidence of complications extimated overall and by type of complication
Average cost for the maintenance of the catheter of each subject (pro day and in total)

Full Information

First Posted
January 29, 2013
Last Updated
October 28, 2015
Sponsor
University of Florence
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1. Study Identification

Unique Protocol Identification Number
NCT01794767
Brief Title
Normal Saline Versus Heparinized Solution Flush for Maintaining Patency of Peripheral Venous Catheters in Children
Official Title
Normal Saline Versus Heparinized Solution Flush for Maintaining Patency of Peripheral Venous Catheters in Children
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Suspended
Why Stopped
difficult recruiting
Study Start Date
January 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Florence

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection of Intravenous Catheter, Phlebitis, Extravasation of Diagnostic and Therapeutic Materials
Keywords
peripheral venous catheter, children.

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
0,9% NaCl flush
Arm Type
Active Comparator
Arm Description
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
Arm Title
Heparin 50U/ml
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
0,9% NaCl flush
Other Intervention Name(s)
Normal Saline
Intervention Description
Normal Saline solution
Intervention Type
Drug
Intervention Name(s)
Heparin 50U/ml
Other Intervention Name(s)
Heparin solution 50 U/ml, Epsodilave
Intervention Description
Heparin solution
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filippo Festini, RN, BSN, MSN
Organizational Affiliation
University of Florence
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meyer Children Hospital
City
Florence
State/Province
Tuscany
ZIP/Postal Code
50139
Country
Italy

12. IPD Sharing Statement

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

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