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
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:
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 →University of Florence is the lead sponsor of 76 studies on the registry; 18 are open to participants now.
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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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Normal Saline solution
Also known as: Normal Saline
Heparin solution
Also known as: Heparin solution 50 U/ml, Epsodilave
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
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
This study is suspended, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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University of Florence