Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00400595
Status:
COMPLETED
Last Update Posted:
2015-03-18
First Post:
2006-11-15
Brief Title:
Use of Ointments in Prevention of Catheter Related Infections in PD
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 ointmentA 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None