Prolonging the Duration of Peripheral Venous Catheters in Cystic Fibrosis People

Summary

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.

Conditions

• Cystic Fibrosis
• Phlebitis

Interventions

PROCEDURE

regular dilution of antibiotic in NS

IV administration of ceftazidime tid diluted in regular NS volume

PROCEDURE

higher dilution of antibiotic in NS

IV administration of ceftazidime tid diluted in larger NS volume

Sponsors & Collaborators

• Italian Cystic Fibrosis Research Foundation

  collaborator OTHER

• Ospedale Meyer

  collaborator OTHER

• University of Florence

  lead OTHER

Principal Investigators

• Filippo Festini, RN, BA, BSN · University of Florence, Department of Pediatrics

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-03-31

Primary Completion

2011-08-31

Completion

2011-08-31

Countries

• Italy

Study Locations