Hemodialysis Infection Prevention Using Polysporin Ointment With Shower Technique in Satellite Centres Pilot Study

NCT02002169 | Unknown

• 1 other identifier: REB 12-0404-AE
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The investigators developed a Shower Technique protocol (STP) for hemodialysis (HD) patients with healed central venous catheter (CVC) exit sites, designed to permit showering but not increase infection risk. Research question: Is it feasible to conduct a randomized control trial comparing the rate of CVC related bacteremia (CRB) in adult satellite HD patients using STP versus standard CVC care alone with 6 month follow up? Study Design: This pilot study is a multi-centre randomized control trial. Eligible participants will be randomized to STP versus standard care after meeting predefined criteria to confirm healed tunneled CVC exit site. Primary Outcome: Feasibility will be determined based on 5 outcome measures: accuracy of the CRB rate documentation in the satellite setting, percentage of patients screened, recruited, educated successfully in the STP (intervention arm), and aspects of STP (% of contaminated patients in the control arm). Study Setting: In satellite units affiliated with 2 academic and 3 community centres in south central Ontario, Canada. Patient Population: Adult satellite HD patients dialyzing via CVC with healed CVC exit sites. Intervention: STP and standard CVC care; or Control: standard CVC care; Analysis: Each measure of feasibility has its statistical threshold for success. If the threshold is reached in 4 of the 5 measures, the full HIPPO SAT study will be deemed feasible. Discussion: A pilot feasibility study of the larger study is critical due to the potential challenges associated with recruitment, compliance and contamination.

Conditions

End Stage Renal Failure on Dialysis

Keywords

Catheter Related Bacteremia

Outcome Measures

Primary Outcomes (1)

• Primary Feasibility Measure of the HIPPO SAT trial: Defined by 5 outcomes

  Outcome Measures of Feasibility 1. The level of agreement between the date the nurse contacts the coordinator to inform them of a suspected infection and the date the culture was sent to the lab from the HD unit 2. The percentage of eligible patients who consent to participate in each participating satellite unit 3. The percentage of satellite HD patients with CVCs who are screened for eligibility 4. The percentage of patients in the Shower Technique arm passing the shower technique test at 3 and 6 months 5. The percentage of patients in the control arm who are contaminated i.e. using aspects of the STP such as chlorhexidine swabs at home at the exit site which they were not using at baseline

  6 months

Secondary Outcomes (2)

• Secondary Feasibility Outcome: The change in Vascular Access Questionnaire (VAQ) score over time using the Shower Technique protocol compared to standard care.

  6 months

• Secondary Feasibility Outcome: The level agreement between the Deep Breath and CVC Seal tests and the blinded photo test

  After consent and prior to randomization

Other Outcomes (8)

• Primary Clinical Outcome Measure: The number of confirmed catheter related bacteremia per 1,000 access days

  6 months

• Secondary Clinical Outcome: Patient satisfaction will be measured by the Vascular Access Questionnaire score

  Baseline, 3 and 6 months

• Secondary Clinical Objective: The mean cost per patient of using the Shower Technique protocol versus standard care

  6 months

Study Arms (2)

Shower Technique Protocol (STP)

EXPERIMENTAL

Participants will be given a minimum 30 minute personalized educational session by the study coordinator. They will be taught safe and clean techniques for showering with their CVC. If the participant passes the Shower Technique Test, they will be provided a pamphlet on the STP, not to be shared with other participants, to be kept as a reference and placed in their bathroom/household. They will also be given the necessary supplies for the STP.

Other: Shower Technique Protocol; Other: Standard CVC Care

Standard CVC care

ACTIVE COMPARATOR

Standard CVC Care consists of cleansing with chlorhexidine 2% or povidone (if allergic to chlorhexidine) at the CVC exit site by trained HD nurses followed by placement of a dry gauze dressing by the HD nurse 1x/week or when clinically indicated. In order to participate in the standard CVC care arm, participating sites must have in their policy that it is trained HD nurses who will apply the Polysporin Triple Ointment after standard cleansing with chlorhexidine 2% or povidone during HD, according to guideline recommendations or as per hospital patient care standards and nursing regulations.

Other: Standard CVC Care

Interventions

Shower Technique Protocol OTHER

Video and educational pamphlets of the STP will be used to assist in training participants randomized to this intervention. The participant must successfully demonstrate the STP on a training mannequin and be deemed by the study coordinator as ready to independently and correctly perform it before proceeding.

Shower Technique Protocol (STP)

Standard CVC Care OTHER

Nuanced differences may be present at participating units; however, the key components of the intervention are 1) HD nurse delivery of CVC care 2) chlorhexidine or povidone cleansing 3) dry gauze dressing 4) standardized frequency. For both STP and control arms, participants whose HD centre uses polysporin triple ointment as part of standard CVC care will continue to have it applied as per program policy.

Shower Technique Protocol (STP); Standard CVC care

Eligibility Criteria

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

You may qualify if:

• Informed written consent obtained (English speaking)
• Age \>18 years
• Requires a CVC as the vascular access: a) end stage kidney disease without a functioning surgically created access; b) end stage kidney disease whose peritoneal dialysis problems require transfer to HD for an anticipated prolonged period
• Passed 2/3 tests of CVC exit site healing (see below)
• Must be willing and able to take a shower as the standard form of body cleansing if randomized to STP
• Trisodium citrate (4%) as standard CVC locking solution
• CVC has been in situ for \> 6 weeks

You may not qualify if:

• Acute kidney failure, likely to be reversible with recovery of renal function
• Non-Tunneled CVC
• Antibiotic use by any route in the week prior to enrolling in the study, including intranasal mupirocin
• On immunosuppressant therapy
• Use of the CVC for purposes other than access for hemodialysis
• Involvement in another interventional study related to their vascular access
• CVC or patient life expectancy \<6 months (e.g. active malignancy; serious comorbidity such as hepatic failure)
• Routine use of tissue plasminogen activator or antibiotic as a locking solution
• CVC insertion in location other than the neck/chest region (IJ or subclavian acceptable)

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Scarborough General Hospital: collaborator
• London Health Sciences Centre: collaborator
• Trillium Health Centre: collaborator
• York Central Hospital, Ontario: collaborator

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M4N 2C4, Canada

RECRUITING

Study Officials

• Charmaine Lok, MD, MSc

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daisy Kosa, MSc. (c)

CONTACT

(905) 745-4773; sarah.kosa@uhn.ca

Cathy Forrester, R.N.

CONTACT

(416) 340-4140; cathy.forrester@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2013
• First Posted: December 5, 2013
• Study Start: December 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 10, 2013

Record last verified: 2013-12

Locations

CA (1)