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| Sponsors and Collaborators: |
University of Florence Italian Cystic Fibrosis Research Foundation, Verona, Italy Meyer Pediatric Hospital, Florence, Italy |
|---|---|
| Information provided by: | University of Florence |
| ClinicalTrials.gov Identifier: | NCT00418470 |
Purpose
Patients with cystic fibrosis (CF) need to frequently undergo courses of IV antibiotic therapy. To avoid a high number of venipunctures peripheral venous catheters (SPVC) or cannulas are used. Because of the irritant action of the drugs used, SPVC's often do not last for the whole antibiotic course (usually of two weeks) and the patient has to be punctured again for the insertion of a new IV line. With the passing of time the veins are more difficult to be found. An alternative to the use of a cannulas is the surgical insertion of a central venous catheter. This intervention may have contraindications or, specially in adolescents, cause unacceptable alterations of the body image.
The aim of this study is to find a way to prolong the duration of the SPVC used by CF patients during antibiotic courses avoiding the irritation of the vein or a phlebitis.
Design of the study: randomized controlled trial. The study will see a collaboration of nurses, physicians and technicians of the Tuscan CF Centre.
The patients that will participate at the study will be randomly assigned to one of the two groups: one group will receive the antibiotics prescribed according to the maximal dilution suggested by the pharmaceutical company, the other will receive a much higher dilution (i.e. a higher volume of Normal Saline), but the time of administration will be the same.
The assessment will regard: the level of inflammation of the vein (with a special visual scale) and the duration of the SPVC.
The hypothesis that is to be proved is that diluting the antibiotic in a higher volume of Normal Saline it is possible to delay or prevent the irritation of the vein and the onset of a phlebitis.
In case that the hypothesis will be confirmed by this study an easy, secure, low cost and immediately available system will be available to reduce the number of venipunctures necessary to complete a course of IV antibiotics.
| Condition | Intervention | Phase |
|---|---|---|
|
Cystic Fibrosis Phlebitis |
Procedure: regular dilution of antibiotic in NS Procedure: higher dilution of antibiotic in NS |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study |
| Official Title: | Prolonging the Duration on Site of Short Peripheral Venous Catheters Used to Administer Intravenous Antibiotics in Cystic Fibrosis Adults. Randomized Controlled Trial on the Effect of Different Concentrations of Antibiotic in Normal Saline |
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
Higher concentration of antibiotic in NS
|
Procedure: regular dilution of antibiotic in NS
IV administration of ceftazidime tid diluted in regular NS volume
|
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B: Experimental
Lower concentration of antibiotic in NS
|
Procedure: higher dilution of antibiotic in NS
IV administration of ceftazidime tid diluted in larger NS volume
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| Contact: Filippo Festini, RN, BA, BSN | +39 347 2108993 | filippo.festini@unifi.it |
| Contact: Cesare Braggion, MD | +39 055 5662474 | cbraggion@qubisoft.it |
| Italy | |
| Meyer Pediatric Hospital (Ospedale Pediatrico Meyer) | Recruiting |
| Florence, Italy, 50132 | |
| Contact: Filippo Festini, RN, BA, BSN +39 347 2108993 filippo.festini@unifi.it | |
| Contact: Cesare Braggion, MD +39 055 5662474 cbraggion@qubisoft.it | |
| Sub-Investigator: Giovanni Taccetti, MD | |
| Principal Investigator: Cesare Braggion, MD | |
| Sub-Investigator: Teresa Repetto, MD | |
| Sub-Investigator: Stella Neri, RN, BSN | |
| Sub-Investigator: Anna Silvia Neri, MD | |
| Sub-Investigator: Maria Chiara Cavicchi, MD | |
| Sub-Investigator: Silvia Boretti, RN, BSN | |
| Sub-Investigator: Riccardo Giuntini, MD | |
| Sub-Investigator: Ilaria Lori, MD | |
| Sub-Investigator: Noemi Vignoli, RN | |
| Sub-Investigator: Ilda Fusco, RN | |
| Principal Investigator: | Filippo Festini, RN, BA, BSN | University of Florence, Department of Pediatrics |
More Information
| Responsible Party: | University of Florence, Italy ( Filippo Festini ) |
| Study ID Numbers: | FFC #19/2006 |
| Study First Received: | January 3, 2007 |
| Last Updated: | January 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00418470 |
| Health Authority: | Italy: Ethics Committee; Italy: Ministry of Health; Italy: National Bioethics Committee |
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Cystic fibrosis Catheterization, peripheral Phlebitis Anti-Bacterial Agents Osmolar Concentration |
|
Peripheral Vascular Diseases Vasculitis Fibrosis Vascular Diseases Ceftazidime Digestive System Diseases Cystic Fibrosis |
Respiratory Tract Diseases Genetic Diseases, Inborn Lung Diseases Phlebitis Pancreatic Diseases Infant, Newborn, Diseases Cystic fibrosis |
|
Pathologic Processes Cardiovascular Diseases |
