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Alcohol Locks for the Prevention of Tunneled Catheter-Related Infections. - Article


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Clinical Trial: Alcohol Locks for the Prevention of Tunneled Catheter-Related Infections.

This study is not yet open for patient recruitment.

Sponsors and Collaborators: Erasmus Medical Center
Stichting Nuts Ohra
Information provided by: Erasmus Medical Center

Purpose

In modern-day medicine, the use of central venous catheters has become unavoidable. However, their use does not come without risk. It puts patients at danger for infectious complications (catheter-related infections, CRI), the most important of which is catheter-related bloodstream infection (CRBSI). CRBSI is associated with significant increase in hospital stay and therefore cost of patient management, morbidity and probably also mortality. There still is an urgent need for effective, cheap and easy to implement measures to prevent CRI that are without risk of developing antibiotic resistance. During use, bacteria can colonize the inner surface of the catheter. This endoluminal route of infection can be prevented to some extent when an antibiotic solution is instilled in the catheter for a long enough time and on a regular basis. However, to avoid resistance from occurring, the use of antibiotics for infection prevention should remain exceptional. The use of an non-toxic antiseptic might be a better alternative. Recently, the use of an alcohol lock solution was suggested as a promising way to prevent CRBSI and the compatibility of polyurethane and silicone catheters submerged in an alcohol solution was publicized with no biomechanical or structural changes detected after 9 weeks of immersion. The major advantage of an alcohol lock solution would be the broad antimicrobial spectrum without the risk of compromising future antibiotic treatment as, in contrast to the use of an antibiotic lock, the development of antibiotic resistance is not of concern. Furthermore it would be cheap and universally available. In this randomised study the efficacy of a 70% alcohol lock solution for the prevention of CRBSI will be compared with placebo when applied for 15 minutes per day.
Condition Intervention Phase
Bacteremia
  Procedure: Alcohol-lock
 Phase II

MedlinePlus related topics:  Bacterial Infections;   Sepsis

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Short Daily Alcohol Locks for the Prevention of Tunneled Catheter Infection in Patients with Haematological Disease. Randomised Placebo Controlled Trial.

Further Study Details: 
Primary Outcomes: Endoluminal catheter related bacteremia.
Secondary Outcomes: All catheter-related bacteremias with DTTP > 2 hours; Catheter survival time; Vancomycin and linezolid use; Incidence of positive catheter tip cultures; Incidence of bacteremia/fungemia (catheter-related or not)
Expected Total Enrollment:  440

Study start: July 2005;  Expected completion: February 2009
Last follow-up: September 2008;  Data entry closure: December 2008

In modern-day medicine, the use of intravascular catheters has become unavoidable. In the United States, hospitals and clinics purchase more than 150 million intravascular devices each year of which more than 5 million are central venous catheters(1). However, their use does not come without risk. It puts patients at danger for mechanical, thrombotic and infectious complications (catheter-related infections, CRI), the most important of which is catheter-related bloodstream infection (CRBSI). CRBSI is associated with significant increase in hospital stay and therefore cost of patient management, morbidity and probably also mortality(2-4). The increase in expenses was estimated to be 15.965 US dollars per patient with a CRBSI in 1994 and even 56167 US dollars in another more recent study(5). It is clear that the prevention of CRI is of utmost importance and will help to decrease patient suffering as well as cost of patient management. Extensive and detailed evidence-based recommendations for the prevention of CRI were recently published(6). However, many topics remain unresolved and there still is an urgent need for effective, cheap and easy to implement preventive measures that are without risk of developing antibiotic resistance. Catheters can become colonized with microorganisms through exoluminal (catheter insertion site) or endoluminal (hub and infusates) routes. It has been shown that, the longer a catheter remains in place, the more important the endoluminal route becomes(7). The endoluminal route of infection can be prevented to some extent when an antibiotic solution is instilled in the catheter for a long enough time and on a regular basis(8-11). However, to avoid resistance from occurring, the use of antibiotics in such a lock for infection prevention should remain exceptional. Although there is evidence to support the concept(12;13), methodologically appropriate clinical data on the use of antiseptic solutions for this purpose are still awaited. Recently, the use of an alcohol lock solution was suggested as a promising way to prevent CRBSI(14) and the compatibility of polyurethane and silicone catheters submerged in an alcohol solution was publicized with no biomechanical or structural changes detected after 9 weeks of immersion(15). The major advantage of an alcohol lock solution would be the broad antimicrobial spectrum without the risk of compromising future antibiotic treatment as, in contrast to the use of an antibiotic lock, the development of antibiotic resistance is not of concern. Furthermore it would be cheap and universally available. In this randomised study the efficacy of a 70% alcohol lock solution for the prevention of CRBSI will be compared with placebo when applied for 15 minutes per day.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria: 1. Patient at least 18 years old 2. Admitted to the haematology department 3. With a tunnelled central venous catheter inserted in the preceding 72hrs

Exclusion Criteria: 1. Known allergy to alcohol or active use of metronidazol (or related 2-nitroimidazole compounds) or Disulfiram (Antabuse)

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00122642


Netherlands
      Erasmus Medical Center, Rotterdam,  3000 CA,  Netherlands
Bart J Rijnders, PhD  31104639222  Ext. 35339    b.rijnders@erasmusmc.nl 

Study chairs or principal investigators

Bart JA Rijnders, MD, PhD,  Principal Investigator,  Erasmus Medical Center   

More Information

Publications

Mermel LA, Farr BM, Sherertz RJ, Raad II, O''''Grady N, Harris JS, Craven DE; Infectious Diseases Society of America; American College of Critical Care Medicine; Society for Healthcare Epidemiology of America. Guidelines for the management of intravascular catheter-related infections. Clin Infect Dis. 2001 May 1;32(9):1249-72. Epub 2001 Apr 3. Review. No abstract available.

Digiovine B, Chenoweth C, Watts C, Higgins M. The attributable mortality and costs of primary nosocomial bloodstream infections in the intensive care unit. Am J Respir Crit Care Med. 1999 Sep;160(3):976-81.

Rello J, Ochagavia A, Sabanes E, Roque M, Mariscal D, Reynaga E, Valles J. Evaluation of outcome of intravenous catheter-related infections in critically ill patients. Am J Respir Crit Care Med. 2000 Sep;162(3 Pt 1):1027-30.

Renaud B, Brun-Buisson C; ICU-Bacteremia Study Group. Outcomes of primary and catheter-related bacteremia. A cohort and case-control study in critically ill patients. Am J Respir Crit Care Med. 2001 Jun;163(7):1584-90.

Dimick JB, Pelz RK, Consunji R, Swoboda SM, Hendrix CW, Lipsett PA. Increased resource use associated with catheter-related bloodstream infection in the surgical intensive care unit. Arch Surg. 2001 Feb;136(2):229-34.

O''''Grady NP, Alexander M, Dellinger EP, Gerberding JL, Heard SO, Maki DG, Masur H, McCormick RD, Mermel LA, Pearson ML, Raad II, Randolph A, Weinstein RA. Guidelines for the prevention of intravascular catheter-related infections. Centers for Disease Control and Prevention. MMWR Recomm Rep. 2002 Aug 9;51(RR-10):1-29.

Raad I, Costerton W, Sabharwal U, Sacilowski M, Anaissie E, Bodey GP. Ultrastructural analysis of indwelling vascular catheters: a quantitative relationship between luminal colonization and duration of placement. J Infect Dis. 1993 Aug;168(2):400-7.

Carratala J, Niubo J, Fernandez-Sevilla A, Juve E, Castellsague X, Berlanga J, Linares J, Gudiol F. Randomized, double-blind trial of an antibiotic-lock technique for prevention of gram-positive central venous catheter-related infection in neutropenic patients with cancer. Antimicrob Agents Chemother. 1999 Sep;43(9):2200-4.

Schwartz C, Henrickson KJ, Roghmann K, Powell K. Prevention of bacteremia attributed to luminal colonization of tunneled central venous catheters with vancomycin-susceptible organisms. J Clin Oncol. 1990 Sep;8(9):1591-7.

Dogra GK, Herson H, Hutchison B, Irish AB, Heath CH, Golledge C, Luxton G, Moody H. Prevention of tunneled hemodialysis catheter-related infections using catheter-restricted filling with gentamicin and citrate: a randomized controlled study. J Am Soc Nephrol. 2002 Aug;13(8):2133-9.

Henrickson KJ, Axtell RA, Hoover SM, Kuhn SM, Pritchett J, Kehl SC, Klein JP. Prevention of central venous catheter-related infections and thrombotic events in immunocompromised children by the use of vancomycin/ciprofloxacin/heparin flush solution: A randomized, multicenter, double-blind trial. J Clin Oncol. 2000 Mar;18(6):1269-78.

Chatzinikolaou I, Zipf TF, Hanna H, Umphrey J, Roberts WM, Sherertz R, Hachem R, Raad I. Minocycline-ethylenediaminetetraacetate lock solution for the prevention of implantable port infections in children with cancer. Clin Infect Dis. 2003 Jan 1;36(1):116-9. Epub 2002 Dec 11.

Allon M. Prophylaxis against dialysis catheter-related bacteremia with a novel antimicrobial lock solution. Clin Infect Dis. 2003 Jun 15;36(12):1539-44. Epub 2003 Jun 6.

Study ID Numbers:  AL-01; SNO-T-07-57
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 21, 2005
ClinicalTrials.gov Identifier:  NCT00122642
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
ClinicalTrials.gov processed this record on 2005-07-26


Source: ClinicalTrials.gov
Cache Date: July 27, 2005

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Page Updated: September 6, 2005
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