Prolonging the Duration of Peripheral Venous Catheters in Cystic Fibrosis People
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00418470|
Recruitment Status : Terminated (impossibility to find volunteers)
First Posted : January 4, 2007
Last Update Posted : October 29, 2015
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 or disease||Intervention/treatment||Phase|
|Cystic Fibrosis Phlebitis||Procedure: regular dilution of antibiotic in NS Procedure: higher dilution of antibiotic in NS||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2007|
|Primary Completion Date :||August 2011|
|Study Completion Date :||August 2011|
Higher concentration of antibiotic in NS
Procedure: regular dilution of antibiotic in NS
IV administration of ceftazidime tid diluted in regular NS volume
Lower concentration of antibiotic in NS
Procedure: higher dilution of antibiotic in NS
IV administration of ceftazidime tid diluted in larger NS volume
- The irritation level of the first vein that is cannulated for the course assessed each day. The assessment will be done utilizing the "Phlebitis Scale" of the Standard of Practice of the Intravenous Nurses Society (Journal of Intravenous Nursing 2000; [ Time Frame: once a day ]
- The number of days that the first short peripheral venous catheter used for the treatment course stays in situ before removal [ Time Frame: once a day ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00418470
|Meyer Pediatric Hospital (Ospedale Pediatrico Meyer)|
|Florence, Italy, 50132|
|Principal Investigator:||Filippo Festini, RN, BA, BSN||University of Florence, Department of Pediatrics|