Prolonging the Duration of Peripheral Venous Catheters in Cystic Fibrosis People

NCT00418470 | Terminated Phase 4

• 1 other identifier: FFC #19/2006
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cystic fibrosis; Catheterization, peripheral; Phlebitis; Anti-Bacterial Agents; Osmolar Concentration

Outcome Measures

Primary Outcomes (2)

• 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;

  once a day

• The number of days that the first short peripheral venous catheter used for the treatment course stays in situ before removal

  once a day

Study Arms (2)

A

EXPERIMENTAL

Higher concentration of antibiotic in NS

Procedure: regular dilution of antibiotic in NS

B

EXPERIMENTAL

Lower concentration of antibiotic in NS

Procedure: higher dilution of antibiotic in NS

Interventions

regular dilution of antibiotic in NS PROCEDURE

IV administration of ceftazidime tid diluted in regular NS volume

A

higher dilution of antibiotic in NS PROCEDURE

IV administration of ceftazidime tid diluted in larger NS volume

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of cystic fibrosis, made accordingly to the Cystic Fibrosis Foundation Guideline (Rosenstein BJ. J Pediatr 1998;132: 589-595)
• age of 18 years or more and ability to consciously express owns informed consent.
• have a prescription done by one of the CF Centre specialist Physicians of an IV antibiotic course of the expected duration of 2 weeks, due to a pulmonary exacerbation, with the association of ceftazidime 3 times daily and tobramycin once daily diluted in Normal Saline.
• absence of clinical conditions that contraindicate the administration of 350ml of Normal Saline in 30 minutes 3 times daily and of 400ml of Normal Saline in 40 minutes.
• no simultaneous anti-inflammatory therapy administered orally, IM or IV
• days have passed from the end of the previous course.
• The IV course will be given to the subject as an inpatient, and he or she will be admitted to our hospital

Sponsors & Collaborators

• University of Florence: lead
• Italian Cystic Fibrosis Research Foundation: collaborator
• Ospedale Meyer: collaborator

Study Sites (1)

Meyer Pediatric Hospital (Ospedale Pediatrico Meyer)

Florence, 50132, Italy

Location

Related Publications (40)

• Cystic Fibrosis Foundation. Patient Registry 2004 Annual Report. Bethesda, Maryland

  BACKGROUND

• Breen L, Aswani N. Elective versus symptomatic intravenous antibiotic therapy for cystic fibrosis. Cochrane Database Syst Rev. 2001;(4):CD002767. doi: 10.1002/14651858.CD002767.

  PMID: 11687159 BACKGROUND

• Littlewood J, Bevan A, Commet G, Govan J. Antibiotic treatment for cystic fibrosis. Cystic Fibrosis Trust 2002. Bromley, UK

  BACKGROUND

• Esmond G, Butler M, McCormack AM. Comparison of hospital and home intravenous antibiotic therapy in adults with cystic fibrosis. J Clin Nurs. 2006 Jan;15(1):52-60. doi: 10.1111/j.1365-2702.2005.01236.x.

  PMID: 16390524 BACKGROUND

• Munck A, Malbezin S, Bloch J, Gerardin M, Lebourgeois M, Derelle J, Bremont F, Sermet I, Munck MR, Navarro J. Follow-up of 452 totally implantable vascular devices in cystic fibrosis patients. Eur Respir J. 2004 Mar;23(3):430-4. doi: 10.1183/09031936.04.00052504.

  PMID: 15065834 BACKGROUND

• Gronowitz E, Strandner K, Herlitz K et all. A national Swedish survey of totally implantable venous access devices (TIVAD) in patients with Cystic Fibrosis (CF). J Cyst Fibros 2003;2:S72

  BACKGROUND

• Tolomeo C, Mackey W. Peripherally inserted central catheters (PICCs) in the CF population: one center's experience. Pediatr Nurs. 2003 Sep-Oct;29(5):355-9.

  PMID: 14651306 BACKGROUND

• Millar-Jones L, Goodchild MC. Peripheral long lines in cystic fibrosis. J Clin Pharm Ther. 1997 Feb;22(1):45-6. doi: 10.1046/j.1365-2710.1997.94075940.x.

  PMID: 9292402 BACKGROUND

• Williams J, Smith HL, Woods CG, Weller PH. Silastic catheters for antibiotics in cystic fibrosis. Arch Dis Child. 1988 Jun;63(6):658-9. doi: 10.1136/adc.63.6.658.

  PMID: 3389899 BACKGROUND

• Campbell WB, Elworthy S, Peerlinck I, Vanslembroek K, Bangur R, Stableforth D, Sheldon CD. Sites of implantation for central venous access devices (ports): a study of the experiences and preferences of patients. Eur J Vasc Endovasc Surg. 2004 Dec;28(6):642-4. doi: 10.1016/j.ejvs.2004.08.002.

  PMID: 15531201 BACKGROUND

• Proesmans M, Boulanger L, De Boeck K. Complications with indwelling catheters in CF patients followed at the universital hospital in Leuven (Belgium). J Cyst Fibros 2002;S172-S173.

  BACKGROUND

• Miall LS, Das A, Brownlee KG, Conway SP. Peripherally inserted central catheters in children with cystic fibrosis. Eight cases of difficult removal. J Infus Nurs. 2001 Sep-Oct;24(5):297-300. doi: 10.1097/00129804-200109000-00003.

  PMID: 11575044 BACKGROUND

• Deerojanawong J, Sawyer SM, Fink AM, Stokes KB, Robertson CF. Totally implantable venous access devices in children with cystic fibrosis: incidence and type of complications. Thorax. 1998 Apr;53(4):285-9. doi: 10.1136/thx.53.4.285.

  PMID: 9741372 BACKGROUND

• Rodgers HC, Liddle K, Nixon SJ, Innes JA, Greening AP. Totally implantable venous access devices in cystic fibrosis: complications and patients' opinions. Eur Respir J. 1998 Jul;12(1):217-20. doi: 10.1183/09031936.98.12010217.

  PMID: 9701441 BACKGROUND

• Jacobs WR, Zaroukian MH. Coughing and central venous catheter dislodgement. JPEN J Parenter Enteral Nutr. 1991 Jul-Aug;15(4):491-3. doi: 10.1177/0148607191015004491.

  PMID: 1823540 BACKGROUND

• Barker M, Thoenes D, Dohmen H, Friedrichs F, Pfannenstiel C, Heimann G. Prevalence of thrombophilia and catheter-related thrombosis in cystic fibrosis. Pediatr Pulmonol. 2005 Feb;39(2):156-61. doi: 10.1002/ppul.20158.

  PMID: 15633202 BACKGROUND

• Strandvik B, Hjelte L, Malmborg AS, Widen B. Home intravenous antibiotic treatment of patients with cystic fibrosis. Acta Paediatr. 1992 Apr;81(4):340-4. doi: 10.1111/j.1651-2227.1992.tb12239.x.

  PMID: 1606396 BACKGROUND

• Giron RM, Martinez A, Maiz L, Salcedo A, Beltran B, Martinez MT, Antelo C, Barrio I, Prados C, Cabanillas J, Ancochea J. [Home intravenous antibiotic treatments in cystic fibrosis units of Madrid]. Med Clin (Barc). 2004 May 8;122(17):648-52. doi: 10.1016/s0025-7753(04)74341-9. Spanish.

  PMID: 15153343 BACKGROUND

• Salcedo A, Giron RM, Beltran B, Martinez A, Maiz L, Suarez L; Fundacion Sira Carrasco. [Consensus conference: home intravenous antibiotic treatment for cystic fibrosis. The Sira Carrasco Foundation. 26 April 2002]. Arch Bronconeumol. 2003 Oct;39(10):469-75. doi: 10.1016/s0300-2896(03)75430-1. No abstract available. Spanish.

  PMID: 14533997 BACKGROUND

• Riethmueller J, Busch A, Damm V, Ziebach R, Stern M. Home and hospital antibiotic treatment prove similarly effective in cystic fibrosis. Infection. 2002 Dec;30(6):387-91. doi: 10.1007/s15010-002-2095-0.

  PMID: 12478330 BACKGROUND

• Kerem E, Conway S, Elborn S, Heijerman H; Consensus Committee. Standards of care for patients with cystic fibrosis: a European consensus. J Cyst Fibros. 2005 Mar;4(1):7-26. doi: 10.1016/j.jcf.2004.12.002. No abstract available.

  PMID: 15752677 BACKGROUND

• The UK CF Nurse Specialist Group. National consensus standards for the nursing management of cystic fibrosis. London, UK7 Cystic Fibrosis Trust; 2001.

  BACKGROUND

• Duncan-Skingle F, Bramwell E. Cystic Fibrosis Home care. In: Hodson ME, Geddes DM. Cystic Fibrosis. Arnold, London, 2000.

  BACKGROUND

• Regueiro Pose MA, Souto Rodriguez B, Iglesias Marono M, Outon Fernandez I, Cambeiro Nunez J, Pertega Diaz S, Pita Fernandez S. [Peripheral venous catheters: incidence of phlebitis and its determining factors]. Rev Enferm. 2005 Oct;28(10):21-8. Spanish.

  PMID: 16304830 BACKGROUND

• Monreal M, Quilez F, Rey-Joly C, Rodriguez S, Sopena N, Neira C, Roca J. Infusion phlebitis in patients with acute pneumonia: a prospective study. Chest. 1999 Jun;115(6):1576-80. doi: 10.1378/chest.115.6.1576.

  PMID: 10378551 BACKGROUND

• Tager IB, Ginsberg MB, Ellis SE, Walsh NE, Dupont I, Simchen E, Faich GA. An epidemiologic study of the risks associated with peripheral intravenous catheters. Am J Epidemiol. 1983 Dec;118(6):839-51. doi: 10.1093/oxfordjournals.aje.a113702.

  PMID: 6650485 BACKGROUND

• Falchuk KH, Peterson L, McNeil BJ. Microparticulate-induced phlebitis. Its prevention by in-line filtration. N Engl J Med. 1985 Jan 10;312(2):78-82. doi: 10.1056/NEJM198501103120203.

  PMID: 3880597 BACKGROUND

• Hessov I, Allen J, Arendt K, Gravholt L. Infusion thrombophlebitis in a surgical department. Acta Chir Scand. 1977;143(3):151-4.

  PMID: 411297 BACKGROUND

• Lanbeck P, Odenholt I, Paulsen O. Perception of risk factors for infusion phlebitis among Swedish nurses: a questionnaire study. J Infus Nurs. 2004 Jan-Feb;27(1):25-30. doi: 10.1097/00129804-200401000-00004.

  PMID: 14734984 BACKGROUND

• Brandt CT. [Phlebitis due to venous catheters. Causes and occurrence]. Ugeskr Laeger. 2000 Aug 21;162(34):4531-4. Danish.

  PMID: 10981220 BACKGROUND

• Neri S, Allegretti N, Vignoli N, FESTINI F. Perception of pain and fear related to invasive procedures in children with cystic fibrosis: a study using CF adults recalls. J Cyst Fibros 2006; 5 (suppl1): 91.

  BACKGROUND

• Richards C, Millar-Jones L, Alfaham M. Assessment of in-line filters to prolong the life of intravenous cannulae in cystic fibrosis patients. J Clin Pharm Ther. 1995 Jun;20(3):165-6. doi: 10.1111/j.1365-2710.1995.tb00643.x.

  PMID: 7593378 BACKGROUND

• Roberts GW, Holmes MD, Staugas RE, Day RA, Finlay CF, Pitcher A. Peripheral intravenous line survival and phlebitis prevention in patients receiving intravenous antibiotics: heparin/hydrocortisone versus in-line filters. Ann Pharmacother. 1994 Jan;28(1):11-6. doi: 10.1177/106002809402800101.

  PMID: 8123947 BACKGROUND

• Festini F, Beneventi R, Vignoli N, Allegretti N, Rontini I, Campigatto E, Grondoni G, Sanasi S, Bongini G. [Factors that influence the duration of peripheral venous catheters used to antibiotic therapy in Cystic Fibrosis patients: results of a study]. Assist Inferm Ric. 2005 Apr-Jun;24(2):91-6. Italian.

  PMID: 16218243 BACKGROUND

• FESTINI F, Beneventi R, Allegretti N, Vignoli N, Chiarelli F. Does oral anti.inflammatory therapy influence the duration of peripheral venous catheters used for IV antibiotic cycles in cystic fibrosis patients ? Pediatr Pulmonol 2005; Suppl 28: 359-360.

  BACKGROUND

• Festini F, Ballarin S, Codamo T, Doro R, Loganes C. Prevalence of pain in adults with cystic fibrosis. J Cyst Fibros. 2004 Mar;3(1):51-7. doi: 10.1016/j.jcf.2003.12.001.

  PMID: 15463887 BACKGROUND

• Ballarin S, Codamo T, Doro R, Loganes C, FESTINI F. Pain in Italian Cystic Fibrosis adult patients: preliminary results of a national nurse led study. J of Cystic Fibrosis 2001; 1: 362.

  BACKGROUND

• Alexander M (editor) Infusion Nursing Standard of Practice of the Intravenous Nurses Society. Journal of Intravenous Nursing 2000; 23. 6S.

  BACKGROUND

• Hockenberry MJ. Wong's clinical manual of pediatric nursing. Mosby 2004, St Louis, Missouri.

  BACKGROUND

• Braun RP, Vecchietti JL, Thomas L, Prins C, French LE, Gewirtzman AJ, Saurat JH, Salomon D. Telemedical wound care using a new generation of mobile telephones: a feasibility study. Arch Dermatol. 2005 Feb;141(2):254-8. doi: 10.1001/archderm.141.2.254.

  PMID: 15724023 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis; Phlebitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Vasculitis

Study Officials

• Filippo Festini, RN, BA, BSN

  University of Florence, Department of Pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 3, 2007
• First Posted: January 4, 2007
• Study Start: March 1, 2007
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: October 29, 2015

Record last verified: 2015-10

Locations

IT (1)