Alcohol Locks for the Prevention of Tunneled Catheter-related Infections

NCT00122642 | Completed Phase 2

• 2 other identifiers: AL-01SNO-T-07-57
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

In modern-day medicine, the use of central venous catheters has become unavoidable. However, their use does not come without risk. It puts patients in danger of infectious complications (catheter-related infections \[CRI\]), the most important of which is catheter-related bloodstream infection (CRBSI). CRBSI is associated with a 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 a 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.

Conditions

Bacteremia

Keywords

catheterization; Catheters, Indwelling

Outcome Measures

Primary Outcomes (1)

• Endoluminal catheter related bacteremia

  at time of catheter removal

Secondary Outcomes (5)

• All catheter-related bacteremias with differential time to positivity (DTTP) > 2 hours

  at time of catheter removal

• Catheter survival time

  at time of catheter removal

• Vancomycin and linezolid use

  at time of catheter removal

• Incidence of positive catheter tip cultures

  at time of catheter removal

• Incidence of bacteremia/fungemia (catheter-related or not)

  at time of catheter removal

Study Arms (2)

1

EXPERIMENTAL

The intervention is the instillation of ethanol 70% solution in the catheter lumen (or lumina) for 15minutes per day during hospital stay and for 15minutes for patients not in the hospital.

Procedure: Alcohol-lock

2

PLACEBO COMPARATOR

The intervention is the instillation of placebo solution in the catheter lumen (or lumina) for 15minutes per day during hospital stay and for 15minutes per week for patients not in the hospital.

Drug: placebo-lock

Interventions

Alcohol-lock PROCEDURE

The intervention is the instillation of ethanol 70% solution in the catheter lumen (or lumina) for 15minutes per day during hospital stay and for 15minutes per week for patients not in the hospital.

1

placebo-lock DRUG

The intervention is the instillation of placebo solution in the catheter lumen (or lumina) for 15minutes per day during hospital stay and for 15minutes per week for patients not in the hospital.

2

Eligibility Criteria

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

You may qualify if:

• Patient at least 18 years old
• Admitted to the haematology department
• Had a tunnelled central venous catheter inserted in the preceding 72 hours

You may not qualify if:

• Known allergy to alcohol or active use of metronidazole (or related 2-nitroimidazole compounds) or disulfiram (Antabuse)

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Stichting Nuts Ohra: collaborator

Study Sites (1)

Erasmus Medical Center

Rotterdam, 3000 CA, Netherlands

Location

Related Publications (16)

• 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. doi: 10.1086/320001. Epub 2001 Apr 3. No abstract available.

  PMID: 11303260 BACKGROUND

• 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. doi: 10.1164/ajrccm.160.3.9808145.

  PMID: 10471627 BACKGROUND

• 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. doi: 10.1164/ajrccm.162.3.9911093.

  PMID: 10988125 BACKGROUND

• 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. doi: 10.1164/ajrccm.163.7.9912080.

  PMID: 11401878 BACKGROUND

• 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. doi: 10.1001/archsurg.136.2.229.

  PMID: 11177147 BACKGROUND

• 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.

  PMID: 12233868 BACKGROUND

• 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. doi: 10.1093/infdis/168.2.400.

  PMID: 8335977 BACKGROUND

• 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. doi: 10.1128/AAC.43.9.2200.

  PMID: 10471564 BACKGROUND

• 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. doi: 10.1200/JCO.1990.8.9.1591.

  PMID: 2202792 BACKGROUND

• 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. doi: 10.1097/01.asn.0000022890.29656.22.

  PMID: 12138146 BACKGROUND

• 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. doi: 10.1200/JCO.2000.18.6.1269.

  PMID: 10715297 BACKGROUND

• 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. doi: 10.1086/344952. Epub 2002 Dec 11.

  PMID: 12491212 BACKGROUND

• Allon M. Prophylaxis against dialysis catheter-related bacteremia with a novel antimicrobial lock solution. Clin Infect Dis. 2003 Jun 15;36(12):1539-44. doi: 10.1086/375234. Epub 2003 Jun 6.

  PMID: 12802753 BACKGROUND

• Maki DG, Crnich CJ, Safdar N. Successful use of a 25% Alcohol Lock Solution for Prevention of Recurrent CVC-Related Bloodstream Infection in a patient on Home TNA. 42nd ICAAC Abstracts, American Society for Microbiology, September 27 - 30, 2002, San Diego, CA, page 320 . 2002.

  BACKGROUND

• A.Aiyangar, W.C.Crone, C.J.Crnich DGM. Effect of Ethanol on the Mechanical Properties of Polyurethane Catheters. Proceedings of the 2002 SEM Annual Conference and Exposition on Experimental and Applied Mechanics . 2002.

  BACKGROUND

• Slobbe L, Doorduijn JK, Lugtenburg PJ, El Barzouhi A, Boersma E, van Leeuwen WB, Rijnders BJ. Prevention of catheter-related bacteremia with a daily ethanol lock in patients with tunnelled catheters: a randomized, placebo-controlled trial. PLoS One. 2010 May 26;5(5):e10840. doi: 10.1371/journal.pone.0010840.

  PMID: 20520776 DERIVED

MeSH Terms

Conditions

Bacteremia

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Bart JA Rijnders, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 19, 2005
• First Posted: July 22, 2005
• Study Start: August 1, 2005
• Primary Completion: June 1, 2009
• Study Completion: September 1, 2009
• Last Updated: September 25, 2009

Record last verified: 2009-09

Locations

NL (1)