Cystic Fibrosis Clinical Trial
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
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.
Status | Terminated |
Enrollment | 60 |
Est. completion date | August 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 - 30 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Italy | Meyer Pediatric Hospital (Ospedale Pediatrico Meyer) | Florence |
Lead Sponsor | Collaborator |
---|---|
University of Florence | Italian Cystic Fibrosis Research Foundation, Ospedale Meyer |
Italy,
Alexander M (editor) Infusion Nursing Standard of Practice of the Intravenous Nurses Society. Journal of Intravenous Nursing 2000; 23. 6S.
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.
Barker M, Thoenes D, Döhmen 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. — View Citation
Brandt CT. [Phlebitis due to venous catheters. Causes and occurrence]. Ugeskr Laeger. 2000 Aug 21;162(34):4531-4. Danish. — View Citation
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. — View Citation
Breen L, Aswani N. Elective versus symptomatic intravenous antibiotic therapy for cystic fibrosis. Cochrane Database Syst Rev. 2001;(4):CD002767. Review. Update in: Cochrane Database Syst Rev. 2012;7:CD002767. — View Citation
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. — View Citation
Cystic Fibrosis Foundation. Patient Registry 2004 Annual Report. Bethesda, Maryland
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. — View Citation
Duncan-Skingle F, Bramwell E. Cystic Fibrosis Home care. In: Hodson ME, Geddes DM. Cystic Fibrosis. Arnold, London, 2000.
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. — View Citation
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. — View Citation
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. — View Citation
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.
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. — View Citation
FESTINI F, Bongini G, Vignoli N, Sanasi S, Campigatto E, Allegretti N, Rontini I, Grondoni G. The number of daily IV administrations of antibiotics influences the duration of peripheral venous catheters in cystic fibrosis patients. Pediatr Pulmonol 2002; suppl 24:356.
Girón RM, Martínez A, Máiz L, Salcedo A, Beltrán B, Martínez 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. Spanish. — View Citation
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
Hessov I, Allen J, Arendt K, Gravholt L. Infusion thrombophlebitis in a surgical department. Acta Chir Scand. 1977;143(3):151-4. — View Citation
Hockenberry MJ. Wong's clinical manual of pediatric nursing. Mosby 2004, St Louis, Missouri.
Jacobs WR, Zaroukian MH. Coughing and central venous catheter dislodgement. JPEN J Parenter Enteral Nutr. 1991 Jul-Aug;15(4):491-3. Erratum in: JPEN J Parenter Enteral Nutr 1992 May-Jun;16(3):298. — View Citation
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. Review. — View Citation
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. — View Citation
Littlewood J, Bevan A, Commet G, Govan J. Antibiotic treatment for cystic fibrosis. Cystic Fibrosis Trust 2002. Bromley, UK
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. — View Citation
Millar-Jones L, Goodchild MC. Peripheral long lines in cystic fibrosis. J Clin Pharm Ther. 1997 Feb;22(1):45-6. — View Citation
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. — View Citation
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. — View Citation
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.
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.
Regueiro Pose MA, Souto Rodríguez B, Iglesias Maroño M, Outón Fernández I, Cambeiro Nuñez J, Pértega Díaz S, Pita Fernández S. [Peripheral venous catheters: incidence of phlebitis and its determining factors]. Rev Enferm. 2005 Oct;28(10):21-8. Spanish. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Salcedo A, Girón RM, Beltrán B, Martínez A, Máiz L, Suárez L; Fundación 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. Review. Spanish. — View Citation
Strandvik B, Hjelte L, Malmborg AS, Widén B. Home intravenous antibiotic treatment of patients with cystic fibrosis. Acta Paediatr. 1992 Apr;81(4):340-4. — View Citation
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. — View Citation
The UK CF Nurse Specialist Group. National consensus standards for the nursing management of cystic fibrosis. London, UK7 Cystic Fibrosis Trust; 2001.
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. — View Citation
Williams J, Smith HL, Woods CG, Weller PH. Silastic catheters for antibiotics in cystic fibrosis. Arch Dis Child. 1988 Jun;63(6):658-9. — View Citation
* Note: There are 41 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Primary | The number of days that the first short peripheral venous catheter used for the treatment course stays in situ before removal | once a day | No |
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