Use of Ointments in Prevention of Catheter Related Infections in PD

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by University Health Network, Toronto.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00400595
First received: November 15, 2006
Last updated: September 2, 2008
Last verified: September 2008
  Purpose

Peritoneal dialysis (PD) is used for the treatment of end-stage renal disease in approximately 25% of patients requiring dialysis in Canada. The most common complication is bacterial infection or 'peritonitis'. Peritonitis causes severe acute abdominal pain and may lead to failure of peritoneal dialysis treatment, hospitalization or death, particularly if left untreated. Amongst the strategies used to prevent peritonitis, patients are instructed on the regular use of a prophylactic ointment around the point where the catheter exits from the body. At the present time most centers in Canada routinely prescribe mupirocin ointment for use at the exit site, however newer ointments have become available. One such ointment is Polysporin Triple. The aim of this study is to determine if catheter related infections can be significantly reduced by the routine application of Polysporin Triple in comparison to mupirocin ointment. A multi-centre, randomized, double blind, controlled study is proposed. Participants will be randomized to either mupirocin or Polysporin Triple and followed for 18 months or until the first catheter related infection, death or catheter removal. The difference in catheter related infection rates will be compared between the two groups. We anticipate the results of this study will allow clinicians to prescribe the ointment most likely to reduce infections. By doing so this will reduce the complication rate associated with peritoneal dialysis and, ultimately improve survival.


Condition Intervention Phase
Peritoneal Dialysis
Drug: Mupirocin ointment
Drug: Polysporin Triple
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Double Blind Study Using Mupirocin Versus Polysporin Triple for the Prevention of Catheter-Related Infections in Patients Treated With Peritoneal Dialysis

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • The primary endpoint is the time to first catheter related infection. [ Time Frame: 2Yrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Removal of the catheter to prevent or halt progression of a catheter related infection [ Time Frame: 2 yrs ] [ Designated as safety issue: No ]
  • Hospitalizations related to catheter related infection [ Time Frame: 2 yrs ] [ Designated as safety issue: No ]
  • Death due to catheter-related infection [ Time Frame: 2 yrs ] [ Designated as safety issue: No ]
  • All-cause mortality [ Time Frame: 2yrs ] [ Designated as safety issue: Yes ]
  • Technique failure (i.e. transfer to hemodialysis) [ Time Frame: 2yrs ] [ Designated as safety issue: No ]
  • Mupirocin or Polysporin Triple resistance [ Time Frame: 2yrs ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: February 2006
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Polysporin tRIPLE ointment (topical ointment in widespread use for other skin lesions)
Drug: Polysporin Triple
Active Comparator: 2
Mupirocin
Drug: Mupirocin ointment
topical ointment (already in widespread clinical use)

Detailed Description:

Peritoneal dialysis (PD) is used for the treatment of end-stage renal disease in approximately 25% of patients requiring dialysis in Canada. The most common PD related complication is infective peritonitis, a syndrome of acute pain, cloudy peritoneal dialysate, and infection. Although many cases of peritonitis can be treated as an outpatient, recurrent or unresolving infections can result in fibrotic changes in the peritoneal membrane, catheter removal or patient death. Gram positive organisms are amongst the commonest causes of PD peritonitis; however, recent trends show an increasing rate of gram negative and fungal infections. Strategies to prevent peritonitis include the use of prophylactic topical mupirocin at the site where the PD catheter exits from the abdominal wall. Despite this and other innovations peritonitis is still diagnosed, on average, in one patient out of every 24 patients followed for a month. The aim of this study is to determine if the incidence of catheter related infections (exit site infection, tunnel infection or peritonitis) is significantly reduced by the routine application of Polysporin Triple in comparison to mupirocin ointment.A multi-centre randomized double blind, controlled study is proposed. Polysporin Triple will be compared against the current standard of care. All patients currently being treated with, or starting onto, peritoneal dialysis will be eligible. Participants will be randomized to one of two treatment arms (mupirocin; Polysporin Triple) and stratified according to a) centre b) vintage (incident versus prevalent), and c) type of PD (chronic ambulatory peritoneal dialysis vs. automated PD). Patients will be followed for 18 months or until the first catheter related infection, death or catheter removal due to technique failure. Catheter related infections will be strictly defined using current guidelines and categorized into exit site infections, infective peritonitis or tunnel infections.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Able and willing to provide informed consent*
  2. Age over 18 years
  3. Has a peritoneal dialysis catheter in situ and

    • Is established on PD for more than 3 months (prevalent patients)
    • Is undergoing training for or has initiated PD within the last 3 months (incident patients)
  4. Medically stable (as defined by primary nephrologist)
  5. Regularly applying mupirocin ointment to catheter exit site

Exclusion Criteria:

  1. Presence of acute renal failure
  2. Catheter related infection at the time of recruitment or within the previous 3 months
  3. Use of an oral or IV antibiotic at the time of randomization or within the previous 1 week.
  4. Known allergy to any component of gentamicin or mupirocin
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00400595

Locations
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Scarborough General Hospital
Toronto, Ontario, Canada, M1P 2V5
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Vanita Jassal, MD University Health Network, Toronto
  More Information

No publications provided by University Health Network, Toronto

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kidney Foundation of Canada
ClinicalTrials.gov Identifier: NCT00400595     History of Changes
Other Study ID Numbers: 05-0850-AE
Study First Received: November 15, 2006
Last Updated: September 2, 2008
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
peritonitis
catheter related infection
exit site ointments
mupirocin
Polysporin Triple

Additional relevant MeSH terms:
Catheter-Related Infections
Infection
Mupirocin
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014