Clinical trial NCT02002169: Hemodialysis Infection Prevention Using Polysporin Ointment With Shower Technique in Satellite Centres Pilot Study
Official title: Hemodialysis Infection Prevention Using Polysporin Ointment With Shower Technique in Satellite Centres (HIPPO SAT) Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: End Stage Renal Failure on Dialysis
Keywords: Catheter Related Bacteremia
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Scarborough General Hospital
name: London Health Sciences Centre
name: Trillium Health Centre
name: York Central Hospital, Ontario
First posted: 2013-12-05
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: CVC related infections are associated with increased morbidity and hospitalization rates, high treatment costs, and poor survival compared to use of an arteriovenous access. To prevent infection, patients should preserve the integrity and dryness of their CVC dressings. Showering should be avoided, as it is difficult to attain full protective coverage of the exit site using dressings and barriers. Wet dressings place patients at increased infection risk, especially if their CVC exit site is not fully healed. However, in a survey of 274 CVC dependent HD patients, 64% indicated that the recommended prohibition to shower was moderately to extremely inconvenient and reduced their quality of life. Additionally 77% of patients admitted to showering at least once while they had a CVC.

While submersion of the CVC in water is discouraged by clinical practice guidelines, they also state that if precautions can be taken to reduce the likelihood of bacterial CVC entry then showering may be acceptable. However, this guidance is opinion based with no evidence to support specific precautions. Thus, to address the patients' desire to shower safely, at least 2 separate dialysis facilities in Ontario, Canada have developed a showering procedure as an alternative method of CVC care. Preliminary data from a small proof-of-concept study of 65 patients suggests acceptable CRB rates (0.46/1000 CVC days) using such showering procedures. The study was conducted in satellite HD units on a select population of patients who were infection-free for 6 months using the same CVC. Satellite units offer dialysis in an outpatient setting for those patients who are stable and require less intensive care than in-centre patients. The satellite HD population is typically younger and healthier, and likely more able to perform showering procedures than in-centre patients. With increasing patients in satellite HD, it is crucial that a pragmatic, yet effective, prophylactic CVC infection strategy be formally tested and established for this setting.

Following the proof-of-concept study, nephrologists, vascular access coordinators, and HD centres from five dialysis centres across Ontario, collaborated to create a formal Shower Technique Protocol (STP) which includes chlorhexidine applicators after showering to minimize the risk of bacterial entry at the CVC exit site. STP is designed specifically for patients with a fully endothelialized CVC tunnel and healed exit site. Participants allocated to STP are able to shower and change their dressing up to 3 times per week. Prior to more widespread implementation of the STP, it is critical to determine whether it is safe for use in patients with healed CVC exit sites. In other words, to confirm that CRB rates in patients using STP are not greater than the CRB rates in patients using the gold standard of CVC care. It is unknown whether using the STP improves patient satisfaction with their CVC care.

Eligibility criteria: Inclusion Criteria

* 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

Exclusion criteria

* 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)

Primary outcomes:
measure: Primary Feasibility Measure of the HIPPO SAT trial: Defined by 5 outcomes
timeFrame: 6 months
Secondary outcomes:
measure: Secondary Feasibility Outcome: The change in Vascular Access Questionnaire (VAQ) score over time using the Shower Technique protocol compared to standard care.
timeFrame: 6 months
measure: Secondary Feasibility Outcome: The level agreement between the Deep Breath and CVC Seal tests and the blinded photo test
timeFrame: After consent and prior to randomization
Other outcomes:
measure: Primary Clinical Outcome Measure: The number of confirmed catheter related bacteremia per 1,000 access days
timeFrame: 6 months
measure: Secondary Clinical Outcome: Patient satisfaction will be measured by the Vascular Access Questionnaire score
timeFrame: Baseline, 3 and 6 months
measure: Secondary Clinical Objective: The mean cost per patient of using the Shower Technique protocol versus standard care
timeFrame: 6 months
measure: Tertiary Clinical Objective: Proportions of patients with CRB, CVC related infection and tunnel infection
timeFrame: 6 months
measure: Tertiary Clinical Objective: The number of days to this first CVC related infection from the date of randomization
timeFrame: 6 months
measure: Tertiary Clinical Objective: The rate of CVC removal due CVC related infection as recorded in the vascular access record
timeFrame: 6 months
measure: Tertiary Clinical Objective: The number of days in hospital due to CVC related infection
timeFrame: 6 months
measure: Tertiary Clinical Objective: The proportion of patients who die from CVC related infection
timeFrame: 6 months
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Charmaine Lok, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: