ClinicalTrials.gg
SuspendedNCT01794767Updated Oct 29, 2015

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

A Phase 4 interventional study of 0,9% NaCl flush and Heparin 50U/ml in Infection of Intravenous Catheter, Phlebitis and Extravasation of Diagnostic and Therapeutic Materials, sponsored by University of Florence. Suspended at 1 site in Italy. Open to participants aged 2 Years to 14 Years. Per ClinicalTrials.gov, last updated 2015-10-29.

Sponsored by University of Florence · Phase 4, Interventional, and Supportive care

Why this study was suspended
difficult recruiting
Phase
Phase 4
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
2 Years to 14 Years
Sex
All
01

Study 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.
02

Conditions studied

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

Browse trials for

Keywords

  • peripheral venous catheter, children.
03

In context

Phlebitis

45 studies on the registry are indexed under Phlebitis; 9 are open to participants now.

This study's planned enrollment of 52 is below the median of 134 across 38 interventional studies indexed under Phlebitis.

Browse Phlebitis studies →

Lead sponsor

University of Florence is the lead sponsor of 76 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 to participate to the study provided by the parents
  • No known 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 and / or anti-inflammatory

Exclusion criteria

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 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 and / or anti-inflammatory
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
52 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Normal Saline solution

    Also known as: Normal Saline

  • DrugHeparin 50U/ml

    Heparin solution

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

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

07

Study locations

1 site
  • Meyer Children Hospital
    Florence, Tuscany 50139, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01794767
Lead sponsor
University of Florence
Responsible party
Filippo Festini (Professor of Nursing, University of Florence) — Principal investigator
First posted
Feb 20, 2013
Start date
Jan 2013
Primary completion
Aug 2014
Completion
Aug 2016 (estimated)
Last update
Oct 29, 2015

Study contacts

Filippo Festini, RN, BSN, MSN
principal investigator · University of Florence

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion